Evaluation of the Bioequivalence of Acarbose in Healthy Chinese People

Abstract

The purpose of this study was to determine whether the reference formulation and test formulation of acarbose are bioequivalent among healthy Chinese subjects based on evaluation of the pharmacodynamic end point. Two clinical trials with acarbose were conducted: study A, a pilot study (n = 12; 50 and 100 mg), and study B, a pivotal study (n = 60; 50 mg). In study A, there was a dose-dependent relationship between 50 mg acarbose and 100 mg acarbose and a significant difference compared with sucrose alone. In study B, after logarithmic conversion, a linear mixed-effects model was used to analyze the maximum serum glucose value and area under the serum glucose-time curve from 0 to 2 hours. The geometric mean ratios (test formulation/reference formulation) were 92.68% and 95.70%, with 90% confidence intervals of 84.08%-102.17% and 84.21%-108.76%, respectively, falling between 80.00% and 125.00%. According to the geometric least-squares mean, the test formulation (or reference formulation) was statistically significantly different as a single sucrose (P