디푸루칸 캅셀(플루코나졸 50 mg)에 대한 플루코나 캅셀의 생물학적 동등성 (Bioequivalence of Flucona Capsule to Diflucan Capsule (Fluconazole 50 mg))

서지정보

· 발행기관 : 한국약제학회
· 수록지 정보 : Journal of Pharmaceutical Investigation / 33권 / 2호 / 9 ~ 140페이지
· 저자명 : 조혜영, 강현아, 이석, 오인준, 임동구, 문재동, 이용복

초록

Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan (Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP VII Apparatus II method at 0.1 M hydrochloride dissolution media. Twenty normal male volunteers, 23.60‘ ±1.88 years in age and 63.57±6.17 kg in body weight, were divided into two groups and a randomized 2´2 cross-over study was employed. After three capsules containing 50 mg as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1 M hydrochloride dissolution media. Besides, the pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax and untransformed Tmax. The results showed that the differences in AUCt, Cmax and Tmax between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(1.01)~log(1.08) and log(1.00)~log(1.12) for AUCt and Cmax, respectively), indicating that Flucona capsule is bioequivalent to Diflucan capsule

영어초록

Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan (Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP VII Apparatus II method at 0.1 M hydrochloride dissolution media. Twenty normal male volunteers, 23.60‘ ±1.88 years in age and 63.57±6.17 kg in body weight, were divided into two groups and a randomized 2´2 cross-over study was employed. After three capsules containing 50 mg as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1 M hydrochloride dissolution media. Besides, the pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax and untransformed Tmax. The results showed that the differences in AUCt, Cmax and Tmax between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(1.01)~log(1.08) and log(1.00)~log(1.12) for AUCt and Cmax, respectively), indicating that Flucona capsule is bioequivalent to Diflucan capsule

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