Bioequivalence and Pharmacokinetic Evaluation of Gliclazide Modified‐Release Tablets in Healthy Chinese Volunteers

This was a single-center, randomized, open-label, two-formulation, and two-cycle crossover trial conducted in 52 healthy Chinese volunteers, under fasting and fed conditions. The participants received oral doses of the test formulation (gliclazide modified-release tablets) and reference formulation (30 mg) during each study period. Blood samples were collected before and up to 72 h after the formulations were administered to determine changes in the pharmacokinetic parameters and adverse reactions, which were then used to evaluate bioequivalence and safety. The geometric mean ratios (GMRs) of C_max, AUC_0-t, and AUC_0-∞ for gliclazide were as follows: 93.9%, 99.2%, and 101.8%, respectively (under fasting conditions); 99.0%, 94.6%, and 98.8%, respectively (under fed conditions). The 90% confidence intervals for the GMRs were within the 80%-125% equivalence interval for both the fasting and fed tests. Ingesting high-fat and high-calorie foods accelerate the absorption rate of gliclazide, does not meaningfully alter the extent of absorption. The safety profiles of the two preparations were similar.