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KMID : 0369820090390030207
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 3 p.207 ~ p.216
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The Bioequivalence of Plunazol Tablet (Fluconazole 150 mg) to Three capsules of Diflucan 50 mg
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Bae Kyun-Seop
Choi Yeong-Jin
Kim Yun-Ah
Lee Min-Seok
Yoon Ji-Won
Hwang Ae-Kyung
Jang Hee-Chul
Lyu Seung-Hyo
Park Si-Hyun
Cho Sang-Heon
Yoo Jeong-Hyun
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Abstract
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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 2×2 crossover trial design. The average age of twenty-four volunteers was 24.78±3.27 year-old, average height was 175.56±5.45 cm, and average weight was 67.24±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.
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KEYWORD
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fluconazole, Diflucan, Plunazol, bioequivalence, LC-MS-MS
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