Bioequivalence study of a fixed-dose combination of Dapagliflozin/ Vildagliptin Sustained Release tablets in healthy adult male subjects: A Randomized, Open-Label, Crossover Study

Abstract

A fixed-dose combination (FDC) of Dapagliflozin and Vildagliptin sustained release (SR) was developed, and its bioequivalence with coadministration of the individual tablets was evaluated in an open-label, randomized, two-treatment, two sequences, two-period, cross-over single-dose study. The study's primary objective was to compare and assess the rate and extent of absorption of Dapagliflozin 10 mg /Vildagliptin SR 100 mg FDC with individual drugs. Twenty-four healthy subjects were randomized, and 23 completed the study. For both Dapagliflozin and Vildagliptin SR, the 90% confidence intervals (CIs) for the ratio (Test product: Reference product) of geometric means of peak plasma concentration (Cmax), the area under the curve from 0 hours to the last measurable concentration (AUC0-t), and AUC-time curve up to infinity (AUC0-∞), were within acceptance criteria for bioequivalence, i.e., 80% to 125%. Overall, both reference and test products were safe and well tolerated.
 Keywords: Bioequivalence, Dapagliflozin, Fixed-dose combination, Pharmacokinetic, Sustained release, Vildagliptin, Type 2 diabetes