生物分析与生物医学杂志

An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Cross Over, Oral Bioequivalence Study of Vildagliptin 50 Mg Tablets of Abbott Laboratories De Colombia vs. Jalra (Vildagliptin) 50 Mg Tablets of Novartis Pharma Stein Ag, in Healthy, Adult, Human Subjects Under Fasting Condition

Abstract

O. Arjun Arumugam*, Geetha Lakshmi G, Srinivas G, Nageswara Rao T, Hurtado-Colorado K, Perez-Perez M, Gavino-Gutierrez AM, Lara C, Higuera MJ and Penaloza

Vildagliptin is dipeptidyl peptidase 4 (DPP-4) inhibitors, that inhibits rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) in the treatment of type 2 diabetes mellitus in adults. The purpose of this study was to evaluate the bioequivalence between Vildagliptin 50 mg Tablets of Abbott Laboratories de Colombia vs. JALRA (Vildagliptin) 50 mg Tablets of Novartis Pharma Stein AG, in healthy subjects under fasting condition. An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, cross over study with washout period of 03 days under fasting condition was carried out in 42 male subjects in the age group of 19 to 43 years who met the study eligibility criteria, participated in the study and all the 42 subjects completed both periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Vildagliptin using bio-analytical method. The 90% confidence interval of C_max and AUC_0-t were 89.32% - 104.32% and 94.52% - 101.11% respectively which were within the pre-defined acceptable limits and the test product is bioequivalent to the reference product.