Bioequivalence study of two fluconazole capsule formulations ion healthy volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 42, Issue 1, 2004, Pages 39-42

  Pereira, R ^a   Fidelis, S ^a   Vanunci, M L P ^a   Oliveira, C H ^b   Mendes, G D ^c   Abib, E ^a   Moreno, R A ^a,d  

^a Synchrop Ass Desenvol Proj Clin   (Brazil)

^b Nautillus Clinic/Biol Attendance   (Brazil)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d Faculty of Americana (FAM)   (Brazil)

Author keywords

Bioavailability; LC MS MS; Pharmacokinetics; Tandem mass spectrometry

Indexed keywords

FLUCONAZOLE; ZOLTEC;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; ELECTROSPRAY MASS SPECTROMETRY; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; REVERSED PHASE LIQUID CHROMATOGRAPHY; TANDEM MASS SPECTROMETRY; VOLUNTEER;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BRAZIL; CAPSULES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; DRUG ADMINISTRATION SCHEDULE; DRUG EVALUATION; FEMALE; FLUCONAZOLE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; THERAPEUTIC EQUIVALENCY;

EID: 0347765875     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Bozzette SA, Gordon RL, Yen A, Rinaldi M, Ito MK, Fierer J 1992 Biliary concentrations of fluconazole in a patient with candidal cholecystitis: case report. Clin Infect Dis 15: 701-703
2. Debruyne D, Ryckelynck J-P, Bigot M-C, Moulin M 1988 Determination of fluconazole in biological fluids by capillary column gas chromatography with a nitrogen detector. J Pharm Sci 77: 534-535
3. DeMuria D, Forrest A, Rich J, Scavone JM, Cohen LG, Kazanjian PH 1993 Pharmacokinetics and bioavailability of fluconazole in patients with AIDS. Antimicrob Agents Chemother 37: 2187-2192
4. Food and Drug Administration 1998 Fed Reg 63: 64222
5. Harris SC, Wallace JE, Foulds G, Rinaldi MG 1989 Assay of fluconazole by megabore capillary gas-liquid chromatography with nitrogen-selective detection. Antimicrob Agents Chemother 33: 714-716
6. Koks CHW, Rosing H, Meenhorst PL, Bult A, Beijnen JH 1995 High-performance liquid chromatographic determination of the antifungal drug fluconazole in plasma and saliva of human immunodeficiency virus-infected patients. J Chromatogr B 663: 345-351
7. Mikano H, Kawazoe K, Sato Y, Izumi K, Ito T, Ito K, Tamaaya T 1999 Penetration of oral fluconazole into gynecological tissues. Antimicrob Agents Chemother 43: 148-151
8. Moraes LA, Lerner FE, Moraes ME, Moraes MO, Corso G, De Nucci G 1999 Fluconazole bioequivalence study: quantification by tandem mass spectrometry. Ther Drug Monit 21: 200-207
9. Physicians' Desk Reference PDR 2001 Medical Economics Company (55th ed), Montvale, NJ
10. Rex JH, Hanson LH, Amantea MA, Stevens DA, Bennett JE 1991 Standardization of a fluconazole bioassay and correlation of results with those obtained by high-pressure liquid chromatography. Antimicrob Agents Chemother 35: 846-850
11. Ribeiro W, Zappi EA, Moraes MEA, Bezerra FAF, Lerner FE, De Nucci G 2000 Comparative bioavailability of two fluconazole capsule formulations in healthy volunteers. Arzneimittelforschung Drug Res 50: 1128-1032