A new solid oral tablet formulation of posaconazole: A randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 11, 2012, Pages 2725-2730

  Krishna, G ^a   Ma, L ^a   Martinho, M ^a   Preston, R A ^b,c   O'mara, E ^a,d  

^a MERCK RESEARCH LABORATORIES   (United States)

^b UNIVERSITY OF MIAMI   (United States)

^c JACKSON MEMORIAL HOSPITAL   (United States)

^d CELGENE CORPORATION   (United States)

Author keywords

Absorption; Exposure; Once daily dosing

Indexed keywords

PLACEBO; POSACONAZOLE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TABLET; TIME TO MAXIMUM PLASMA CONCENTRATION; XEROSTOMIA;

ADMINISTRATION, ORAL; ADULT; ANTIFUNGAL AGENTS; FEMALE; HUMAN EXPERIMENTATION; HUMANS; MALE; MIDDLE AGED; PLACEBOS; TABLETS; TRIAZOLES;

EID: 84867584428     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks268     Document Type: Article

References (11)

1. Cornely OA, Maertens J, Winston DJ et al. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med 2007; 356: 348-59.
2. Ullmann AJ, Lipton JH, Vesole DH et al. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med 2007; 356: 335-47.
3. Walsh TJ, Raad I, Patterson TF et al. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial. Clin Infect Dis 2007; 44: 2-12.
4. Raad II, Hachem RY, Herbrecht R et al. Posaconazole as salvage treatment of invasive fusariosis in patients with underlying hematologic malignancy and other conditions. Clin Infect Dis 2006; 42: 1398-403.
5. Courtney R, Wexler D, Radwanski E et al. Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults. Br J Clin Pharmacol 2003; 57: 218-22.
6. Krishna G, Moton A, Ma L et al. The pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers. Antimicrob Agents Chemother 2009; 53: 958-66.
7. w (Posaconazole) Oral Suspension mg/mL. 2010.
8. Krishna G, Ma L, Vickery D et al. Effect of varying amounts of a liquid nutritional supplement on the pharmacokinetics of posaconazole in healthy volunteers. Antimicrob Agents Chemother 2009; 53: 4749-52.
9. Krishna G, Ma L, Martinho M et al. A single dose phase I study to evaluate the pharmacokinetics of posaconazole new tablet and capsule formulations relative to oral suspension. Antimicrob Agents Chemother 2012; doi:10.1128/AAC.00222-12.
10. Shen JX, Krishna G, Hayes RN. A sensitive liquid chromatography and mass spectrometry method for the determination of posaconazole in human plasma. J Pharm Biomed Anal 2007; 43: 228-36.
11. Moton A, Krishna G, Wang Z. Tolerability and safety profile of posaconazole: evaluation of 18 controlled studies in healthy volunteers. J Clin Pharm Ther 2009; 34: 301-11.