The relative bioavailability of domestic glidazide tablets(II)

Objective: To assess the relative bioavailability of domestic gliclazide tablets (Ⅱ). Methods: In a randomized, single-dose, open-label and crossover study, the plasma gliclazide concentrations collected from 20 healthy volunteers that randomly received domestic (test) or joint-adventure manufactured (reference) gliclazide tablets (80mg) were measured by RP-HPLC. Results: The pharmacokinetic parameters of test and reference tablets were as follows: T_(max)(7.9±0.9) vs (8.0±0.4)h; C_(max)(3.44±1.01) vs (3.24±0.97)mg·L~(-1); AUC_(0-48)(47.32±9.60) vs (47.73±10.83) mg·h·L~(-1). No statistical difference was found in the parameters of two tablets. The relative bioavailability of test tablets (Ⅱ)was (100.3±12.2)%. Conclusion: Two gliclazide tablets were bioequivalent.