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KMID : 0369820060360020143
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 2 p.143 ~ p.148
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Bioequivalence of Procare Tablet to Proscar(R) Tablet (Finasteride 5 mg)
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강현아/Kang HA
조혜영/이용복/Cho HY/Lee YB
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Abstract
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Finasteride [N?(1,1?dimethylethyl)?3?oxo?4?aza?5α?androst?1?ene?17β?carboxamide] is a 4-aza-3-oxosteroidal inhibitor of human 5α?reductase. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, Proscar® (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.7±2.24 years in age and 67.2±8.55kg in body weight, were divided into two groups and a randomized 2\time2 cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt,Cmax,andTmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt,Cmax and untransformed Tmax. The results showed that the differences between two formulations based on the reference drug, Proscar®, were 6.39, 4.65 and -13.9% for AUCt,Cmax,andTmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.800 to log 1.25 (e.g.,log0.990∼log1.14andlog0.977∼log1.13forAUCtandCmax,respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to Proscar® tablet.
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KEYWORD
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Finasteride, Proscar, Procare, Bioequivalence, HPLC
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