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KMID : 0369820040340050419
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 5 p.419 ~ p.425
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Bioequivalence of Kuhnil Propiverine Hydrochloride Tablet to BUP-4 Tablet (Propiverine Hydrochloride 20㎎)
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조혜영/Cho HY
박은자/강현아/백승희/김세미/박찬호/오인준/문재동/이용복/Park EJ/Kang HA/Baek SH/Kim SM/Park CH/Oh IJ/Moon JD/Lee YB
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets. BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, 23.73 ± 2.79 years in age and 67.04 ± 7.93 kg in body weight, were divided into two groups and a randomized 2 x 2 cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine in serum were determined using HPLC method with UV detector. The dis-solution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC" C _(max) and T _(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC, C_(max), and untransformed T_(max). The results showed that the differences between two formulations based on the BUP-4 were 0.17%, 7.98% and 4.55% for AUC,, C_(max), and respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically trans-formed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(0.88)-log(l .12) and log(0.90)-log(l.15) for AUC, and _(max), respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.
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KEYWORD
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Propiverine, BUP-4, Kuhnil Propiverine Hydrochloride, Bioequivalence, HPLC
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