Pharmacokinetics and bioequivalence study of Gliclazide tables in Chinese healthy volunteers

Objective To study the relative bioavailability and bioequivalence of Gliclazide tables (test) to the normal tables (reference) in Chinese healthy volunteers. Methods 20 male healthy volunteers were randomized to receive a single crossover oral dose of 80 mg test tables or reference tables.The plasma concentration of Gliclazide was determined by HPLC method. Results The method was linear in the 0.104～12.48 μg/ml concentration range (r=0.999 88);The mean recovery rate was 90.125%～104.6%,the inter-day RSD and intra-day RSD were less 10%;The main pharmacokinetic parameters without significant difference of test and reference Gliclazide tables were as follows: Tmax:(4.4±0.9) and (4.0±0.9)h;Cmax:(4.8±0.6) and (5.3±0.8)mg/L;AUC0~48 h:(86±29) and (88±33)mg·L-1·h-1;AUC0~∞:(99±45) and (103±58)mg·L-1·h-1;T1/2:(13±4) and (14±5)h,F0~48 h was(99±9)%. Conclusion The test Gliclazide tables were bioequivalent to the reference tables.