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KMID : 0369820070370040255
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 4 p.255 ~ p.261
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Bioequivalence of Nimegen(TM) Soft Capsule to RoAccutane(R) Soft Capsule (Isotretinoin 10 mg)
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Yang Seung-Kwon
Chang Kyu-Young
Lee Kyung-Ryul
Lee Hee-Joo
La Soo-Kie
Lee Yun-Young
Yoon Mi-Kyeong
Lew Soo-Hyun
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Abstract
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A bioequivalence study of soft capsule (Medica Korea Pharma. Co., Ltd.) to soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. (the area under the plasma concentration-time curve from time zero to 48 hr) was calculated by the linear trapezoidal rule method. (maximum plasma drug concentration) and (time to reach ) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed . No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the ratio and the ratio for were , respectively. These values were within the acceptable bioequivalence intervals of . Thus, our study demonstrated the bioequivalence of with respect to the rate and extent of absorption.
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KEYWORD
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Isotretinoin, RoAccutane(R) soft capsule, Nimegen(TM) soft capsule, Bioequivalence, HPLC
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