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KMID : 0391020030110020112
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2003 Volume.11 No. 2 p.112 ~ p.119
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Comparative Bioavailability Study of Fluconazole Formulation
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Kwon Gee-Youn
Yoon Sung-Do
Cho Dong-Hyun
Gil Young-Sig
Kim Soo-Kyung
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Abstract
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Background: This study was conducted to evaluate the bioavailability of Fluconazole formulation in healthy Korean volunteers. Furthermore, the bioequivalence of Flukan^{circledR} capsule, a fluconazole preparation from Korea United Pharm, Inc., was determined.
Methods:The study employed a randomized, two-way crossover Latin square design with a two-week washout period. The test product was Flukan^{circledR} capsule (Korea United Pharm Inc., South Korea) and the reference was Diflucan^{circledR} capsule (Pfizer Inc.). The two products were administered in 150 mg single oral doses into 26 healthy Korean volunteers. Serial blood samples were collected for a period of 120 hours. Plasma fluconazole concentrations of the two brands were measured by HPLC using UV detector, and the pharmacokinetic parameters including AUC_t,;C_{max},;T_{max}, and half-life were determined from plasma concentrations of both formulations.
Results: Both formulations were well tolerated in 26 volunteers. Mean AUC_t,;C_{max} of Flukan^{circledR} capsule were 1.068 (90%;confidence;interval:;1.0057{leqdeltaleq}1.1349) and 1.017 (90%;confidence;interval:;0.9633{leqdelta\leq}1.0749) compared to those of Diflucan^{circledR} capsule. Mean half-life of Flukan^{circledR} capsule was 30.41{pm}5.44 and that of Diflucan^{circledR} capsule was 30.74{pm}5.86 hr. The powers (1-{beta}) for AUC_t;and;C_{max} were above 90%. The pharmacokinetic parameters (AUC_t,;C_{max},;T_{ max}) were analyzed statistically with K-BE test 2002 (KFDA).
Conclusion :No significant differences between two formulations were observed in terms of AUC_t;and;C_{max}, the main pharmacokinetic parameters used for bioequivalence evaluation. The results satisfied the bioequivalence criteria of KFDA guidelines, and Flukan^{circledR} capsule was determined to be bioequivalent to Diflucan^{circledR} capsule.
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KEYWORD
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Fluconazole, Bioavailability, Bioequivalence, HPLC, Korean volunteers
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