Romanian Society of Pharmaceutical Sciences
 

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BIOEQUIVALENCE OF TWO FORMULATIONS OF GLICLAZIDE IN A RANDOMIZED CROSSOVER STUDY IN HEALTHY CAUCASIAN SUBJECTS UNDER FED CONDITION

DIANA IOANA POP 1,2*, MONICA OROIAN 1,2, SANDEEP BHARDWAJ 2, ADRIANA MARCOVICI 2, ARSHAD KHUROO 3, RAVI KOCHHAR 4, LAURIAN VLASE 1

1.Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, "Iuliu Haţieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania
2.Clinical Pharmacology and Pharmacokinetics Department, Terapia SA - a Sun Pharma Company, Cluj-Napoca, Romania
3.Clinical Pharmacology and Pharmacokinetics Department, Gurugram, India
4.R&D Formulation Development, Gurugram, India

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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.