Bioequivalence evaluation of two formulations of fluconazole 150 mg capsule in healthy Arab men

Biopharmaceutics and Drug Disposition

Volumn 26, Issue 4, 2005, Pages 143-146

  Al Gaai, Eman ^a   Lockyer, Marilyn ^a   Al Digither, Saleh ^a   Hammami, Muhammad M ^a  

^a KING FAISAL SPECIALIST HOSPITAL AND RESEARCH CENTER   (Saudi Arabia)

Author keywords

Bioavailability; Bioequivalence; Fluconazole; Pharmacokinetics

Indexed keywords

FLUCONAZOLE;

ADULT; ARAB; AREA UNDER THE CURVE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; ETHNOLOGY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; REVIEW; VALIDATION PROCESS;

ABSORPTION; ADMINISTRATION, ORAL; ADULT; ANTIFUNGAL AGENTS; ARABS; BIOLOGICAL AVAILABILITY; CAPSULES; CROSS-OVER STUDIES; DRUGS, GENERIC; FLUCONAZOLE; HUMANS; MALE; THERAPEUTIC EQUIVALENCY;

EID: 19144364519     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.443     Document Type: Review

References (9)

1. Moraes LA, Lerner FE, Moraes MEA, Moraes MO, Corso G, De Nucci G. Fluconazole bioequivalence study: quantification by tandem mass spectrometry. Ther Drug Monit 1999; 21: 200-207.
2. Hutchinson TA, Shahan DR (eds). DRUGDEX® System. Thomson MICROMEDEX: Greenwood Village, Colorado (Edition expires 3/2004.).
3. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15: 657-680.
4. Sauter R, Steinijans VW, Diletti E, Bohm A, Schultz HU. Presentation of results from bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1992; 30: 233-256.
5. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1990; 28: 72-78.
6. Ribeiro W, Zappi EA, Moraes ME, Bezerra FA, Lerner FE, de Nucci G. Comparative bioavailability of two fluconazole capsule formulations in healthy volunteers. Arzneimittelforschung 2000; 50: 1028-1032.
7. Manorot M, Rojanasthien N, Kumsorn B, Teekachunhatean S. Pharmacokinetics and bioequivalence testing of generic fluconazole preparations in healthy Thai volunteers. Int J Clin Pharm Ther 2000; 38: 355-359.
8. Health Canada. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations. Ottawa, Ontario, Canada 1996. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-b_e.html/ [01 June 2004].
9. Sobue S, Tan K, Shaw L, Layton G, Hust R. Comparison of the pharmacokinetics of fosfluconazole and fluconazole after single intravenous administration of fosfluconazole in healthy Japanese and Caucasian volunteers. Eur J Clin Pharmacol 2004; 60: 247-253.