Bioequivalence of two formulations of gliclazide in a randomized crossover study in healthy caucasian subjects under fed condition

Abstract

This study was aimed to assess the bioequivalence of a test product, Gliclazide 60 mg modified release tablets (Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries, India) and a reference product Diamicron® 60 mg modified release tablets (Les Laboratoires Servier Industrie, France) in 26 healthy Caucasian volunteers under fed condition. The design of the study was single-dose, two-treatment, two-period, and two-sequence crossover study in fed condition with a washout period of 21 days. Blood samples were collected for a period of 96 h after drug administration in each period. Gliclazide plasma concentrations were determined by a LC-MS/MS method. Pharmacokinetic analysis used a non-compartmental model. The logarithmically transformed data of Cmax and AUCs were analysed using ANOVA. The 90% confidence intervals were within the acceptance range of 80.00-125.00% and there is no significant difference in pharmacokinetic characteristics between the products. The investigated products are bioequivalent under fed condition.