Amoxicillin/clavulanic acid (875/125): Bioequivalence of a novel Solutab® tablet and rationale for a twice-daily dosing regimen

International Journal of Clinical Pharmacology and Therapeutics

Volumn 42, Issue 3, 2004, Pages 165-173

  Sourgens, H ^a   Bertola, M A ^b   Verschoor, J S C ^b   Kuipers, M ^b   Rayer, B ^c  

^a UNIVERSITY OF MÜNSTER   (Germany)

^b ASTELLAS PHARMA INC   (Japan)

^c Medical Department   (Germany)

Author keywords

Amoxicillin calvulanic acid 875 125; Bioequivalence; PD break points; PK PD parameters; Twice daily dosing

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; FORCID SOLUTAB; SOLUTAB;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; FEMALE; HAEMOPHILUS INFLUENZAE; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; MINIMUM INHIBITORY CONCENTRATION; MORAXELLA CATARRHALIS; NAUSEA; NORMAL HUMAN; OPEN STUDY; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; TABLET FORMULATION; VOMITING;

EID: 2442436618     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP42165     Document Type: Article

References (29)

1. Allen GD 1990 MODFIT: a pharmacokinetics computer program. Biopharm Drug Dispos 11: 477-498
2. Andes D, Craig WA 1998 In vivo activities of amoxicillin and amoxicillin-clavulanate against Streptococcus pneumoniae: application to breakpoint determinations. Antimicrob Agents Chemother 42: 2375-2379
3. Balgos AA, Rodriguez-Gomez G, Nasnas R, Mahasur AA, Margono BP, Tinoco-Favila JC, Sansores-Martinez RH, Hassan M, Beppo O, Wongsa A, Cukier A, Vargas F 1999 Efficacy of twice-daily amoxycillin/clavulanate in lower respiratory tract infections. IJCP 53: 325-330
4. Behre U, Burow HM, Quinn P, Cree F, Harrison HE, Green N 1997 Efficacy of twice-daily dosing of amoxicillin/clavulanate in acute otitis media in children. Infection 25: 163-166
5. Calver AD, Walsh SW, Quinn PF, Baran C, Lonergan V, Singh KP, Orzolek W and the Lower Respiratory Tract Infection Collaborative Study Group 1997 Dosing of amoxicillin/clavulanate given every 12 hours is as effective as dosing every 8 hours for treatment of lower respiratory tract infection. Clin Infect Dis 24: 570-574
6. Cook RC, Zachariah J, Cree F, Harrison HE, Green N 1996 Efficacy of twice-daily amoxicillin/clavulanate (" Augmentan-Duo" 400/57 in mild to moderate lower respiratory tract infection in children. Br J Clin Pract 50: 125-128
7. Cooper CE, Slocombe B, White AR 1990 Effect of low concentrations of clavulanic acid on the in vitro activity of amoxicillin against β-lactamase-producing Branhamella catarrhalis and Haemophilus influenzae. J Antimicrob Agents 26: 371-380
8. CPMP 1998 Note for guidance on the investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 Draft, 17 December 1998
9. Craig WA 1998 Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 26: 1-12
10. Craig WA 2001 Re-evaluating current antibiotic therapy. Respir Med 95 (Suppl A): 12-19
11. Damrikarnlert L, Jauregui AC, Kzadri M, the Augmentan 454 Study Group 2000 Efficacy and safety of amoxyciillin/clavulanate (augmentan twice daily versus three times daily in the treatment of acute otitis media in children. J Chemother 12: 79-87
12. Diletti E, Hauschke D, Steinijans VW 1992 Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43. Int J Clin Pharmacol Ther Toxicol 30: 59-62
13. Drusano GL, Craig WA 1997 Relevance of pharmacokinetics and pharmacodynamics in the selection of antibiotics for respiratory tract infections. J Chemother 9: 38-44
14. Felmingham D, Grüneberg RN and the Alexander Project Group 2000 The Alexander Project 1996-1997: latest susceptibility data from this international study of bacterial pathogens from community-acquired lower respiratory tract infections. J Antimicrob Chemother 45: 191-203
15. Gould IM 2000 Towards a common susceptibility testing method? J Antimicrob Chemother 45: 757-762
16. Grimm H, Bauernfeind A 1997 Das Alexander-Projekteine internationale Studie über Antibiotika-Sensibilität bakterieller Erreger bei ambulant erworbenen Atemwegsinfektionen. Z Antimikrob Antineoplast Chemother 15: 93-98
17. Hoberman A, Paradise JL, Burch DJ, Valinski WA, Hedrick JA, Aronovitz GH, Drehobl MA, Rogers JM 1997 Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentan) for treatment of acute otitis media in children. Pediatr Infect Dis J 16: 463-470
18. Kober HD 2000 Verlängerung des Dosierungsintervalls von Amoxicillin/Clavulansäure. Krankenhauspharmazie 21: 53-58
19. Mouton JW, Punt N 2001 Use of the t > MIC to choose between different dosing regimens of β-lactam antibiotics. J Antimicrob Chemother 47: 500-501
20. National Committee for Clinical Laboratory Standards 2002 Wayne, USA, document M2-A7 and M7-A5.22: no.1
21. Rodvold KA 2001 Pharmacodynamics of antiinfective therapy: taking what we know to the patient's bedside. Pharmacotherapy 21: 319S-330S
22. Schito GC, Manelli S, Pesce A and the A lexander Project Group 1997 Trends in the activity of macrolide and β-lactam antibiotics and resistance development. J Chemother 9 (Suppl 3): 18-28
23. Seggev JS, Enrique RR, Brandon ML, Larsen LS, Van Tuyl RA, Rowinski CA, the Acute Bacterial Maxillary Sinusitis Collaborative Study Group 1998 A combination of amoxicillin and clavulanate every 12 hours vs every 8 hours for treatment of acute bacterial maxillary sinusitis. Arch Otolaryngol Head Neck Surg 124: 921-923
24. Sourgens H, Steinbrede H, Verschoor JSC, Bertola MA, Rayer B 2001 Bioequivalence study of a novel Solutab tablet formulation of amoxicillin/clavulanic acid versus the originator film-coated tablet. Int J Clin Pharmacol Ther 39: 75-82
25. Thorburn CE, Molesworth SJ, Sutherland R, Rittenhouse S 1996 Postantibiotic and post β-lactamase inhibitor effects of amoxicillin plus clavulanate. Antimicrob Agents Chemother 40: 2796-2801
26. Turnidge JD 1998 The pharmacodynamics of β-lactams. Clin Infect Dis 27: 10-22
27. Van Hoogdalem EJ, Terpstra Y, Krauwinkel WJJ, Volkers-Kamermans NJ, Baven ALM, Verschoor JSC 1996 Multiple dose bioequivalence study with josamycin propionate, a drug with highly variable kinetics, in healthy volunteers. Int J Clin Pharmacol Ther 34: 202-207
28. Wardrop J, Ayres JW 1997 Bioequivalence of a novel amoxicillin/clavulanate chewable tablet formulations. Res Commun Pharmacol Toxicol 2: 175-191
29. Woodnutt G, Berry V 1999 Two pharmacodynamic models for assessing the efficacy of amoxicillin-clavulanate against experimental respiratory tract infections caused by strains of Streptococcus pneumoniae. Antimicrob Agents Chemother 43: 29-34