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디푸루칸 캡슐 50 mg (3 캡슐, 플루코나졸 150mg)에 대한 푸루나졸 정 150mg의 생물학적 동등성
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  • 디푸루칸 캡슐 50 mg (3 캡슐, 플루코나졸 150mg)에 대한 푸루나졸 정 150mg의 생물학적 동등성
저자명
장희철,이민석,유정현,류승효,조상헌,최연진,황애경,김윤아,박시현,윤지원,배균섭,Chang. Hee-Chul,Lee. Min-Suk,Ryu. Chong-Hyon,Lyu. Seung-Hyo,Cho. Sang-Heon,Choi. Yeo
간행물명
藥劑學會誌
권/호정보
2009년|39권 3호|pp.207-216 (10 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${ imes}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${pm}$3.27 year-old, average height was 175.56${pm}$5.45 cm and average weight was 67.24${pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.