Acarbose 제제의 약력학적 평가 및 생물학적동등성 시험법에 대한 연구

• 영문명: Methods for Pharmacodynamic Analysis and Proposed Protocols for Bioequivalence Study of Acarbose
• 발행기관: 대한약학회
• 저자명: 배정우(Jung-Woo Bae) 장춘곤(Choon-Gon Jang) 이석용(Seok-Yong Lee)
• 간행물 정보: 『약학회지』제51권 제6호 (2007년), 440~446쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2007.12.31

영문 초록

Arcabose is a competitive inhibitor of the intestinal α-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over (3×3) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug (Glucoby？？ 100 mg, Lot # D043) or test drug (Glucoby？？ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. Cmax, AUC0-2, AUC0-4, ΔCmax, ΔAUC0-2 and ΔAUC0-4 of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.

키워드

acarbose postprandial glucose pharmacodynamics bioequivalence