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Fluconazole 제제의 생체이용률 비교시험
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  • Fluconazole 제제의 생체이용률 비교시험
저자명
권지윤,윤성도,조동현,길영식,김수경,Kwon. Gee-Youn,Yoon. Sung-Do,Cho. Dong-Hyun,Gil. Young-Sig,Kim. Soo-Kyung
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2003년|11권 2호|pp.112-119 (8 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

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 $(90%;confidence;interval:;0.9633{leqdeltaleq}1.0749)$ 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 $(1-{eta})$ 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.