Neuraminidase inhibitors for preventing and treating influenza in adults and children

Cochrane Database of Systematic Reviews

Volumn 2014, Issue 4, 2014, Pages

  Jefferson, Tom ^a   Jones, Mark A ^b   Doshi, Peter ^c   Del Mar, Chris B ^d   Hama, Rokuro ^e   Thompson, Matthew J ^f   Spencer, Elizabeth A ^a   Onakpoya, Igho J ^a   Mahtani, Kamal R ^a   Nunan, David ^a   Howick, Jeremy ^a   Heneghan, Carl J ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF QUEENSLAND   (Australia)

^c UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^d BOND UNIVERSITY   (Australia)

^e Japan Institute of Pharmacovigilance   (Japan)

^f UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; PLACEBO; SIALIDASE INHIBITOR; ZANAMIVIR; ANTIVIRUS AGENT; ENZYME INHIBITOR; SIALIDASE;

ABDOMINAL PAIN; ANTIBODY TITER; BRONCHITIS; CHEMOPROPHYLAXIS; COUGHING; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; HEADACHE; HOSPITAL ADMISSION; HUMAN; INFLUENZA; INFLUENZA A; INFLUENZA B; KIDNEY DISEASE; LOW DRUG DOSE; MENTAL DISEASE; META ANALYSIS; NAUSEA; NAUSEA AND VOMITING; OTITIS MEDIA; PNEUMONIA; PRIORITY JOURNAL; REVIEW; RISK REDUCTION; SINUSITIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; VOMITING; ADULT; ANTAGONISTS AND INHIBITORS; CHILD; DRUG LEGISLATION; DRUG SCREENING; EUROPE; HEALTH STATUS; INFLUENZA, HUMAN; JAPAN; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); UNITED KINGDOM; UNITED STATES;

ADULT; ANTIVIRAL AGENTS; CHILD; DRUG EVALUATION; ENZYME INHIBITORS; EUROPE; GREAT BRITAIN; HEALTH STATUS; HUMANS; INFLUENZA, HUMAN; JAPAN; LEGISLATION, DRUG; NEURAMINIDASE; OSELTAMIVIR; PNEUMONIA; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; ZANAMIVIR;

EID: 84942782497     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD008965.pub4     Document Type: Review

References (305)

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16. No authors listed. A double-blind, randomised, placebo-controlled, multicenter study in 2 parallel groups, to investigate the efficacy and safety of inhaled zanamivir (10 mg bd via Diskhaler), for 5 days, in children aged 5 to 12 years with symptomatic influenza A and / or B infection. Data on file. 2661410
17. No authors listed. A double-blind, randomised, placebo-controlled, parallel-group, multicentre study to investigate the efficacy and safety of inhaled zanamivir 10 mg administered once a day for 10 days in the prevention of transmission of symptomatic influenza A and B viral infections within households. Data on file. 2661412
18. No authors listed. A double-blind, randomized, placebo-controlled, parallel-group, multicentre study to investigate the efficacy and safety of inhaled zanamivir 10 mg administered once a day for 28 days in the prevention of symptomatic influenza A and B viral infections in community-dwelling high-risk populations. Data on file. 2661414
19. No authors listed. A double-blind, randomized, placebo-controlled, multicenter, parallel-group study to investigate the efficacy and safety of zanamivir administered twice or four times a day for the treatment of influenza A and B viral infections. Data on file. 2661416
20. No authors listed. A double-blind, randomised, placebo-controlled, multicentre, parallel-group study to demonstrate the efficacy and safety of zanamivir in the prevention and/or progression of influenza A and B viral infections. Data on file. 2661418
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22. No authors listed. A double-blind, randomised, placebo-controlled multicentre study to investigate the efficacy and safety of zanamivir therapy in the prevention of progression of influenza A and B viral infections. Data on file. 2661422
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24. No authors listed. A double-blind, randomized, parallel-group, multi-center study to investigate the efficacy and safety of inhaled zanamivir 10 mg administered once a day compared to the standard of care in controlling nursing home influenza outbreaks. Data on file. 2661426
25. No authors listed. A double-blind, randomized, placebo-controlled, parallel-group, multi-center study to investigate the efficacy and safety of inhaled zanamivir 10 mg once a day in controlling nursing home influenza outbreaks. Data on file. 2661428
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28. No authors listed. A double-blind, randomised, placebo-controlled, parallel-group, multicentre study to investigate the efficacy and safety of inhaled zanamivir in preventing progression of influenza A and B viral infections. Data on file. 2661434
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30. Campion K, Gummer M, Keene O. A double-blind, randomized, placebo-controlled, parallel-group, multicenter study to investigate the efficacy and safety of zanamivir administered twice daily in the treatment of influenza A and B viral infections in adults. Data on file. 2661438
31. Man CY, Keene ON, Challoner T (Challoner Associates). A double-blind, randomised, placebo-controlled, parallel-group, multicentre study to investigate the efficacy and safety of inhaled zanamivir (GG167) 10 mg administered twice a day for five days in the treatment of symptomatic influenza A and B viral infections in adolescents and adults. Data on file. 2661440
32. No authors listed. A double-blind, randomized, stratified, placebo-controlled study of oseltamivir in the treatment of influenza in children with asthma. Data on file. 2661442
33. No authors listed. A trial to investigate efficacy to reduce development of influenza symptoms in influenza infected patients treated with GG167 (protocol number PE-01 phase II clinical trial). A double-blind double-dummy, randomized, placebo-controlled, parallel group, multicenter study to investigate the efficacy reducing development of influenza symptoms and, safety and rout of administration of GG 157 when orally inhaled GG 167 10 mg, 6.4 mg nebulized intranasally or the combination of inhaled GG167 10 mg plus intranasal GG167 6.4 mg was administered twice day for 5 days in the treatment of influenza A and B viral infections. Data on file. 2661444
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36. No authors listed. Efficacy of Ro 64-0796 when used as chemoprophylaxis against natural influenza infection. Data on file. 2661450
37. Grosse M. A multi-center, randomized, double-blind, placebo-controlled, parallel group study of oseltamivir treatment in elderly patients with influenza. Data on file. 2661452
38. No authors listed. A double-blind randomised placebo controlled study of Ro 64-0796 (also known as GS4104) used in elderly subjects for the prevention of clinical influenza during influenza season. Data on file. 2661454
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40. No authors listed. A double-blind, randomized, stratified, placebo-controlled study of Ro 64-0796 (also known as GS 4104) in the treatment of children with influenza. Data on file. 2661458
41. Gerster T. A double-blind, randomized, stratified, placebo-controlled study of oseltamivir phosphate (Ro 64-0796, also known as GS 4104) in the treatment of influenza in children with chronic asthma. Data on file. 2661460
42. No authors listed. A double-blind randomised placebo controlled study of Ro 64-0796 (also known as GS4104) for the prevention of clinical influenza post exposure in families. Data on file. 2661462
43. McCarvil M. A double-blind, stratified, randomised, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza in chronically ill adults. Data on file. 2661464
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46. No authors listed. A double-blind, randomised, stratified, placebo-controlled study of oseltamivir in the treatment of influenza infection in patients. Data on file. 2661470
47. A post-marketing surveillance to monitor the safety of RELENZA (zanamivir) administered in Korean subjects according to the prescribing information. Data on file. 2661472
48. An open label, single-dose, five-way crossover study examining relative oral bioavailability of zanamivir with bioenhancing excipients following direct release into mid-small intestine using gamma scintigraphy and the InteliSite Companion Capsule in healthy subjects. Data on file. 2661474
49. An open-label, non-randomized, single-dose study to evaluate serum zanamivir pharmacokinetics following intravenous administration to human subjects with renal impairment compared to subjects without renal impairment. Data on file. 2661476
50. Special drug use investigation for Relenza (resistant appearance). Data on file. 2661478
51. Special drug use investigation for Relenza (efficacy). Data on file. 2661480
52. Drug use investigation for Relenza. Data on file. 2661482
53. Prophylactic efficacy of Relenza against influenza A and B. Data on file. 2661484
54. A randomized, placebo controlled, 3-way crossover study to investigate the safety, tolerability, and pharmacokinetics of repeat dose zanamivir/placebo 10 mg administered twice daily for 5 days by a rotahaler compared to the diskhaler in healthy subjects. Data on file. 2661486
55. An open-label, multi-center, single arm study to evaluate the safety and tolerability of intravenous zanamivir in the treatment of hospitalized adult, adolescent and pediatric subjects with confirmed influenza infection. Data on file. 2661488
56. Collection of patients' background information Relenza® sentinel site monitoring program in Japan. Data on file. 2661490
57. A phase III international, randomized, double-blind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza. Data on file. 2661492
58. A study of GG167 single blind, single administration - phase I. Data on file. 2661494
59. A study of GG167 single blind, single administration - phase I. Data on file. 2661496
60. A study of GG167 single blind, single administration - phase I. Data on file. 2661498
61. A study of GG167 single blind, single administration - phase I. Data on file. 2661500
62. (Zanamivir trial. Title unknown). Data on file. 2661502
63. A randomized open label study comparing the efficacy, safety, and tolerability of oral administration of amantadine and ribavirin with oseltamivir versus oseltamivir to influenza A virus infected immunocompromised subjects. Data on file. 2661504
64. A single-center, open-label, single dose, exploratory study in Caucasian and Japanese healthy subjects to investigate the pharmacokinetics of oseltamivir and its metabolite in plasma and cerebrospinal fluid. Data on file. 2661506
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67. A study to investigate the pharmacokinetics of GG167 in subjects with impaired renal function. Data on file. 2661512
68. (Zanamivir trial. Title unknown). Data on file. 2661514
69. (Zanamivir trial. Title unknown). Data on file. 2661516
70. Single ascending oral dose study of tolerability, safety and pharmacokinetics (including effect of food) of the neuraminidase inhibitor Ro 64-0796 in healthy male volunteers. Data on file. 2661518
71. Multiple oral dose study of the tolerability, safety and PK of the neuraminidase inhibitor Ro64-0796: direct PK comparison between Japanese and Caucasian subjects. Data on file. 2661520
72. Phase II clinical study of oseltamivir phosphate (Ro64-0796) for the treatment of influenza in children. Data on file. 2661522
73. Post-marketing clinical study of oseltamivir phosphate on nighttime ECG in healthy adult male subjects. Data on file 2008. 2661524
74. Early administration of oral oseltamivir increases the benefits of influenza treatment. Data on file. 2661526
75. An observational study to assess the accuracy of diagnosis of influenza in community pharmacies. Data on file. 2661528
76. Phase IV study on Tamiflu® capsule 75 in the elderly aged 80 years or older (a single dose oral administration study for assessing pharmacokinetics in the elderly not infected with influenza virus). Data on file. 2661530
77. Impact of oseltamivir (Tamiflu ®) in post-exposure prophylaxis influenza on mortality and morbidity in institutionalised elderly people. [Impact de l'oseltamivir (Tamiflu®) en prophylaxie antigrippale post-exposition, sur la mortalité et la morbidité des personnes âgées institutionnalisées.]. Data on file. 2661532
78. Evaluation of combination therapy with oseltamivir and zanamivir versus monotherapy in the treatment of virologically confirmed influenza in primary care a randomised double blind controlled trial study. Data on file. 2661534
79. Efficacy and safety of combination therapies with oseltamivir & zanamivir or oseltamivir & amantadine versus oseltamivir monotherapy in the treatment of seasonal influenza A infection. Data on file. 2661536
80. An unblinded, comparative, randomized study of influenza A/H1N1 2009 resistance in patients with standard and double dose oseltamivir treatment. Data on file. 2661538
81. Viral shedding/resistance with double duration oseltamivir in infected patients (New Zealand). Data on file. 2661540
82. Viral shedding/resistance with standard dose/duration oseltamivir in infected patients (UK). Data on file. 2661542
83. A study of the relative oral bioavailability of the antiflu medicine oseltamivir (Tamiflu®) in patients in the intensive care unit. Data on file. 2661544
84. Viral shedding/resistance with double dose oseltamivir in infected patients (Australia). Data on file. 2661546
85. Nasogastric administration of OP in infected patients with respiratory failure. Data on file. 2661548
86. Oseltamivir pharmacokinetics in morbid obesity. Data on file. 2661550
87. Open-label pharmacokinetic of oseltamivir in healthy obese Thai adult subjects. Data on file. 2661552
88. A randomized, double-blinded controlled trial comparing high vs standard dose oseltamivir in severe, influenza infection in ICU. "ROSII Study". Data on file. 2661554
89. Probing the functional expression of carboxyl esterase in preterm neonates using oseltamivir: a pragmatic observational study. Data on file. 2661556
90. Plasma levels of oseltamivir in H1N1 infected patients supported by extracorporeal membrane oxygenation: a single-centre cohort study. Data on file. 2661558
91. Effect of probenecid on the pharmacokinetics of oseltamivir. Data on file. 2661560
92. A prospective study to assess household transmission of influenza and emergence and transmissibility of drug resistance to oseltamivir following treatment of children with influenza A and B. Data on file. 2661562
93. High-dose versus standard-dose oseltamivir for the treatment of severe influenza and avian influenza: a phase II double-blind, randomized clinical trial. Data on file. 2661564
94. A study on higher-dose oseltamivir treatment's impact on viral clearance and clinical recovery in adults hospitalized with influenza. Data on file. 2661566
95. A study of the pharmacology of oseltamivir (Tamiflu) in pregnancy. Data on file. 2661568
96. Pharmacokinetics of Tamiflu® (oseltamivir) in patients receiving extracorporeal membrane oxygenation (ECMO) and or continuous venovenous hemodialysis (CVVHD). Data on file. 2661570
97. Pharmacokinetics of oseltamivir in critically ill adult patients. Data on file. 2661572
98. Observational study on the pharmacokinetics of oseltamivir in the treatment of influenza during lactation. Data on file. 2661574
99. Phase I, open-label study to evaluate steady-state serum and pulmonary pharmacokinetics following intravenous administration of zanamivir in healthy adult subjects. Data on file. 2661576
100. Phase 1, open-label study to evaluate potential pharmacokinetic interactions between orally-administered oseltamivir and intravenous zanamivir in healthy Thai adult subjects. Data on file. 2661578
101. A double-blind, randomised, placebo-controlled study to evaluate the effect of inhaled zanamivir 10 mg od for 28 days on anti-haemagglutinin antibody production (HAI titre) following co-administration with Fluvirin™ trivalent influenza vaccine in healthy adult subjects. Data on file. 2661580
102. An open label, randomized evaluation of the direct measurement of zanamivir concentrations in respiratory secretions following a single dose inhalation of 10 mg RELENZA™ via DISKHALER in health volunteers. Data on file. 2661582
103. An open-label, multi-center study of the patient instructional leaflet for RELENZA DISKHALER. Data on file. 2661584
104. Pharmacokinetics of zanamivir (GG167) following inhaled administration in pediatric subjects with signs and symptoms of respiratory illness. Data on file. 2661586
105. Pilot, cluster randomised, open, single centre, parallel group study to evaluate the efficacy and safety of zanamivir in controlling influenza outbreaks and preventing the development of resistant influenza cases in a high risk nursing home population, compared with usual care. Data on file. 2661588
106. Cass LMR, Brown J, Pickford M, Fayinka S, Newman SP, Johansson CJ, et al. Pharmacoscintigraphic evaluation of lung deposition of inhaled zanamivir in healthy volunteers. Clinical Pharmacokinetics 1999 36:Suppl 1 (21-31). Not posted to GSK CTR. 2661590
107. A study to evaluate the effect of repeat doses of GG167 dry powder on pulmonary function and bronchial hyper-responsiveness in asthmatic subjects. Data on file. 2661592
108. A GG167 Pharmacokinetic Study to Select a Regimen for Prophylaxis. Data on file. 2661594
109. A phase I double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of intravenous peramivir in healthy subjects. Data on file. 2661596
110. An open-label, multiple dose, randomized, three-period crossover study in healthy volunteers to evaluate the effect of co-administration of amantadine 100 mg BID and oseltamivir 75 mg BID on the pharmacokinetic properties of amantadine and oseltamivir. Data on file. 2661598
111. TCAD vs. monotherapy for influenza A in immunocompromised patients. Data on file. 2661600
112. A phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous peramivir in hospitalized subjects with confirmed or suspected influenza infection. Data on file. 2661602
113. A pharmacokinetic/pharmacodynamic and safety evaluation of investigational intravenous peramivir in children with influenza disease (CASG 117). Data on file. 2661604
114. (Oseltamivir trial. Title unknown). Data on file. 2661606
115. Multiple ascending oral dose study of the tolerability, safety and pharmacokinetics of the neuraminidase inhibitor Ro 64-0796 in healthy volunteers. Data on file. 2661608
116. Study of the PD and PK of the neuraminidase inhibitor Ro 64-0796 (GS4104) in the treatment of volunteers experimentally infected with human influenza B virus. Data on file. 2661610
117. An excretion balance and pharmacokinetic study of Ro 64-0796 after a single oral dose of 14C-labelled Ro 64-0796 and an intravenous dose of 14C-labelled Ro 64-0802 in healthy male subjects. Data on file. 2661612
118. Study of the pharmacokinetics and absolute bioavailability of the neuraminidase inhibitor Ro 64-0796. Data on file. 2661614
119. An open-label study of the effect of cimetidine and probenecid on the pharmacokinetics of Ro 64-0796/GS4104 in healthy subjects. Data on file. 2661616
120. An open-label bioequivalence and food effect study of the clinical trial and market formulations of Ro 64-0796 in healthy subjects. Data on file. 2661618
121. No authors listed. A palatability study of the neuraminidase inhibitor (Ro 64-0796), formulated as an oral formulation. Data on file. 2661620
122. No authors listed. Study of the pharmacokinetics and pharmacodynamics of the neuraminidase inhibitor Ro 64-0796 (GS4104) in the prophylaxis of experimental infection of volunteers with the human influenza B virus. Data on file. 2661622
123. An open-label bioequivalence and food effect study of the clinical trial and market formulations of Ro 64-0796 in healthy subjects. Data on file. 2661624
124. An open-label study of pharmacokinetics of Ro 64-0796/GS4104 in children. Data on file. 2661626
125. Study of the pharmacodynamics of the neuraminidase inhibitor in the treatment of subjects experimentally infected with the human influenza B virus. Data on file. 2661628
126. Palatability testing of the neuraminidase inhibitor Ro 64-0796 in children. Research Report No. W-144154/27 October 1999. Data on file. 2661630
127. An open-label, two-way crossover pharmacokinetic drug interaction study of neuraminidase inhibitor Ro 64-0796/GS4104 and amoxicillin in healthy volunteers. Data on file. 2661632
128. Palatability testing of the neuraminidase inhibitor Ro 64-0796 in children. Data on file. 2661634
129. A single center, open label, multiple dose oral oseltamivir suspension study in end-stage-renal disease (ESRD) patients on hemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD). Data on file. 2661636
130. An open-label, multiple dose, randomized, three-period crossover study in healthy subjects to evaluate the effect of co-administration of oseltamivir (RO0640796) 75 mg twice daily and rimantadine 100 mg twice daily on the pharmacokinetic properties of oseltamivir and rimantadine. Data on file. 2661638
131. A study of intravenous oseltamivir [Tamiflu] in infants with influenza. Data on file. 2661640
132. A study of intravenous Tamiflu (oseltamivir) in children with influenza. Data on file. 2661642
133. PK and safety of multiple ascending doses of iv oseltamivir in healthy adults. Data on file. 2661644
134. A randomized, double-blind trial evaluating conventional and high dose Tamiflu in the treatment of influenza in immunocompromised patients. Data on file. 2661646
135. A double-blind, randomized, placebo controlled multicenter trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients. Data on file. 2661648
136. An influenza resistance information study (IRIS). Data on file. 2661650
137. A randomized, multicenter trial of oseltamivir [Tamiflu] doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days to evaluate the effect on the duration of viral shedding in influenza patients with pandemic (H1N1) 2009. Data on file. 2661652
138. Avian/pandemic influenza registry final report, 30 August 2012. Data on file. 2661654
139. A randomized, multicenter, parallel study of the safety, pharmacokinetics and the effect on viral activity of intravenously administered Tamiflu [oseltamivir] in patients with influenza over 13 years of age. Data on file. 2661656
140. A prospective, observational safety study in children ≤ 24 months of age receiving oseltamivir for the treatment or prophylaxis of influenza infection. Data on file. 2661658
141. An open-label, prospective, single oral dose study evaluating the pharmacokinetics, safety and tolerability of oseltamivir (Tamiflu) in adult subjects on peritoneal dialysis (PD) using a rapid cycle regimen to simulate automated peritoneal dialysis (APD) and in adult subjects with creatinine clearance from 10-30 mL/min not on dialysis. Data on file. 2661660
142. A single oral dose, multi-center, open label study of the pharmacokinetics, safety and tolerability of Ro 04-0796/GS4104 in ESRD subjects on hemodialysis and peritoneal dialysis. Data on file. 2661662
143. An open label study of the pharmacokinetics of oseltamivir (Ro 64-0796) in children aged 0 - 5 years old after a single dose. Data on file. 2661664
144. Double-blind, randomized, placebo controlled, single ascending i.v. dose study of the tolerability (with emphasis of nausea and vomiting), safety, pharmacokinetics of oseltamivir (Ro 64-0796) and its active metabolite oseltamivir carboxylate (Ro 64-0802) in healthy male volunteers. Data on file. 2661666
145. GS97802 - challenge flu A treatment. Data on file. 2661668
146. GS-97801 challenge flu A treatment. Data on file. 2661670
147. Single ascending oral dose study of the tolerability, safety and pharmacokinetics (including effect of food) of the neuraminidase inhibitor GS4104 in healthy volunteers. Data on file. 2661672
148. Multiple ascending oral dose study of the tolerability, safety and pharmacokinetics of the neuraminidase inhibitor, GS4104 in healthy volunteers. Data on file. 2661674
149. Multiple ascending oral dose study of the tolerability, safety and pharmacokinetics of the neuraminidase inhibitor Ro 64-0796 in healthy elderly volunteers. Data on file. 2661676
150. Multiple oral dose study of the pharmacokinetics, tolerability and safety of the neuraminidase inhibitor Ro 64-0796 in patients with renal impairment. Data on file. 2661678
151. Study of the safety and pharmacokinetics of the neuraminidase inhibitor Ro 64-0796 in healthy volunteers when administered concomitantly with paracetamol (acetaminophen). Data on file. 2661680
152. An open-label, relative bioavailability study of the phase III pediatric clinical trial and market formulations of Ro 64-0796 in healthy volunteers. Data on file. 2661682
153. An open-label, three-way crossover, pharmacokinetic drug interaction study of neuraminidase inhibitor Ro 64-0796 and aspirin in healthy subjects. Data on file. 2661684
154. An open label bioequivalence and food effect study of the enteric coated and immediate release formulations of oseltamivir in healthy subjects. Data on file. 2661686
155. An open-label, bioequivalence study of the phase III pediatric clinical trial and market oral suspension formulations of Ro 64-0796 in healthy volunteers. Data on file. 2661688
156. An open-label, relative bioavailability study of the market suspension (with improved process), the clinical trial suspension and market capsule formulation of Ro 64-0796 (Tamiflu, oseltamivir) in healthy subjects. Data on file. 2661690
157. A study of the pharmacokinetics of oseltamivir (Ro 64-796) and its active metabolite Ro 64-0802 following single oral dosing of Ro 64-0796 to healthy volunteers and patients with moderate hepatic impairment. Data on file. 2661692
158. A pharmacokinetic drug interaction study of oseltamivir (Ro 64-0796) and antacid in healthy volunteers. Data on file. 2661694
159. A randomized, double blind, parallel group, placebo controlled study of the effect of oseltamivir on ECG intervals in healthy subjects. Data on file. 2661696
160. A randomized, open label study of the site of absorption of oseltamivir in healthy subjects using an Enterion capsule. Data on file. 2661698
161. Clinical pharmacokinetics of cyclosporine or mycophenolate with and without a concurrent single dose of oseltamivir phosphate in patients with a renal transplant. Data on file. 2661700
162. Comparison of the pharmacokinetics of Ro 64-0802 following a single dose of oseltamivir phosphate either in a capsule or a drinking solution. Data on file. 2661702
163. A combined single ascending dose, multiple ascending dose and exploratory bioavailability study to investigate the safety, tolerability and pharmacokinetics of intravenous Ro 64-0796 in healthy volunteers. Data on file. 2661704
164. Oseltamivir treatment for children less than 24 months of age with influenza. Data on file. 2661706
165. An open-label, randomized 2-period crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of warfarin, and the pharmacokinetics, safety and tolerability of oseltamivir, when given in combination. Data on file. 2661708
166. An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu®) in the treatment of infants 0 to < 12 months of age with confirmed influenza infection. Data on file. 2661710
167. A double-blind, randomized, stratified pilot study of Ro 64-0796 (also known as GS4104) in children with influenza. Data on file. 2661712
168. (Oseltamivir trial. Title unknown). Data on file. [Mentioned in EMA EPAR dated 23 March 2006 pdf page 14 but possibly same trial as WV 16193]2661714
169. A randomized, open-label, parallel group study of oseltamivir used for management of influenza in households. Data on file. 2661716
170. Kashiwagi S, Watanabe A, Ikematsu H, Awamura S, Okamoto T, Uemori M, et al. Laninamivir octanoate for post-exposure prophylaxis of influenza in household contacts: a randomized double blind placebo controlled trial. Journal of Infection and Chemotherapy 2013;19:740-9. 2661718
171. Economic and social benefits of treating and preventing influenza in aged care facilities. Data on file. 2661720
172. A randomized, open label study to evaluate the effect of Tamiflu on viral shedding and on serum and cytoplasmic inflammatory cytokine concentrations in patients with laboratory-confirmed influenza. Data on file. 2661722
173. Pilot study to develop a model to evaluate nosocomial transmission of influenza. Data on file. 2661724
174. A double-blind, randomized, placebo-controlled study of early oseltamivir treatment of influenza in children 1-3 years of age. Data on file. 2661726
175. A phase 4, multi-center, randomized, double blind, placebo controlled study, to evaluate the safety of inhaled zanamivir 10 mg versus placebo and oral oseltamivir 75 mg versus placebo for influenza prophylaxis in healthy volunteers for 16 weeks. Data on file. 2661728
176. Efficacy of oseltamivir in reducing the duration of clinical illness, viral shedding, and transmissibility reduction within households among participants in an influenza disease burden surveillance cohort in urban Dhaka, Bangladesh. Data on file. 2661730
177. Viral shedding/resistance with standard dose/duration oseltamivir in infected patients (South Africa). Data on file. 2661732
178. A randomised controlled trial on the effect of post-exposure oseltamivir prophylaxis on influenza transmission in nursing homes (PEPpIE). Data on file. 2661734
179. A phase II, multicenter, randomized, double-mask, placebo-controlled study to evaluate the efficacy and safety of intramuscular peramivir in subjects with uncomplicated acute influenza. Data on file. 2661736
180. A phase II, multicenter, randomized, double-mask, double-dummy study comparing the efficacy and safety of peramivir administered intravenously once daily versus oseltamivir administered orally twice daily in adults with acute serious or potentially life-threatening influenza. Data on file. 2661738
181. A phase 3 multicenter, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of intramuscular peramivir in subjects with uncomplicated acute influenza. Data on file. 2661740
182. Monitoring influenza severity and transmission on Tamiflu (MISTT). Data on file. 2661742
183. A phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intramuscular peramivir in subjects with uncomplicated acute influenza. Data on file. 2661744
184. A phase II, multicenter, randomized, placebo-controlled, study to evaluate the efficacy and safety of intramuscular peramivir 600 mg in subjects with uncomplicated acute influenza. Data on file. 2661746
185. A phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza. Data on file. 2661748
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