Details

Autor(en) / Beteiligte

• 조혜영
• Hea Young Cho
• 박은자
• Eun Ja Park
• 강현아
• Hyun Ah Kang
• 백승희
• Seung Hee Baek
• 김세미
• Se Mi Kim
• 박찬호
• Chan Ho Park
• 오인준
• In Joon Oh
• 문재동
• Jai Dong Moon
• 이용복
• Yong Bok Lee

Titel

단보 : 비유피-4 정(염산프로피베린 20㎎)에 대한 건일염산프로피베린 정의 생물학적 동등성

Ist Teil von

• Journal of pharmaceutical investigation, 2004-10, Vol.34 (5), p.419

Ort / Verlag

한국약제학회

Erscheinungsjahr

2004

Beschreibungen/Notizen

• 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.