Bioequivalence of Two Formulations of Gliclazide in a Randomized Crossover Study in Healthy Caucasian Subjects Under Fasting Conditions

Abstract This study aimed to investigate the bioequivalence of 2 formulations of gliclazide modified‐release tablets 60 mg in 48 healthy Caucasian volunteers under fasting conditions. A test product, Gliclazide MR (Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries, India), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single‐dose, 2‐treatment, 2‐period, 2‐sequence crossover design in a fasted condition with a washout period of 21 days. Blood samples were collected for 96 hours after drug administration. Drug plasma concentrations were determined by a liquid chromatography–tandem mass spectrometry method. Analysis of pharmacokinetic characteristics was based on a noncompartmental model. The logarithmically transformed data of C max and AUC were analyzed for 90% confidence intervals using analysis of variance. There was no significant difference in pharmacokinetic characteristics between the products, and the 90% confidence intervals were within the acceptance range of 80.00%–125.00%. The investigated products were bioequivalent under fasted conditions.