Comparative Bioequivalence Study of 2 Fixed-Dose Combinations of Vildagliptin and Metformin at a Tablet Strength of 50/1000 mg in Moroccan Volunteers

Abstract

This study evaluates the bioequivalence of 2 fixed-dose combinations of vildagliptin (50 mg) and metformin (1000 mg) in healthy Moroccan volunteers. A single-dose, randomized, simple-blind, 2-sequence, 2-period crossover design was conducted with 30 participants, 28 of whom completed the study. The test product was compared to the reference product (by measuring pharmacokinetic parameters, including maximum plasma concentration, area under the concentration–time curve (AUC) from time zero to the last measurable time point, AUC from time zero extrapolated to infinity, and time to maximum concentration. Blood samples were collected at predefined intervals after dosing, and plasma concentrations of vildagliptin and metformin were determined using a validated liquid chromatography–tandem mass spectrometry method. Pharmacokinetic analysis showed comparable results between the 2 formulations. Both products met the bioequivalence criteria of 80%-125% for maximum plasma concentration and AUC. Safety assessments revealed no serious adverse events, and both products were well tolerated. The study concluded that the test product is bioequivalent to the reference, supporting its therapeutic interchangeability in managing type 2 diabetes mellitus.