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Bioequivalence of Two Formulations of Gliclazide in a Randomized Crossover Study in Healthy Caucasian Subjects Under
Diana Ioana Pop1,2, Monica Oroian1,2, Sandeep Bhardwaj2
1Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, University of Medicine and Pharmacy "Iuliu Haţieganu,", Cluj-Napoca, Romania.
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 Cmax 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.
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