A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn®) and Galvusmet® 50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions

Abstract

Abstract Aim Vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn®) is being developed for the treatment of type 2 diabetes mellitus. An open label, crossover, bioequivalence study (phase I) was conducted to assess the bioequivalence between Sensityn® Film Coated Tablets (Test Product/Alpha Pharma Industries, a subsidiary of Cigalah Healthcare LLC, KAEC, Saudi Arabia) and Galvusmet® Film Coated Tablets (Reference product/Novartis Pharma, Switzerland), in healthy adults under fed conditions. Safety and tolerance were evaluated as secondary endpoints. Materials and methods A randomized study with two treatments, two periods, crossover, open-label, laboratory-blind, single dose, with a washout period of seven days under fed conditions in 36 healthy male subjects. These were administered medicinal drug product (Sensityn®) or the reference medicinal product (Galvusmet®); both as a single 50 mg/1000 mg oral dose, under fed conditions. Blood samples were collected for pharmacokinetic analysis before treatment and until 24.00h post-dosing in each study period. ANOVA analysis (test sequence, subjects’ nested within sequence, product and period effect) was performed using a 5% significance level for logarithmic and untransformed data for Cmax AUC0-t and AUC0-∞ and for untransformed data for Tmax, Kelimination (λz) and half-life. Results The results showed that Cmax, AUC0-t, and AUC0-∞ have passed the 90% CI acceptance limits of 80.00%–125.00% for vildagliptin and metformin. Consequently, the bioequivalence of Sensityn® and Galvusmet® film coated tablets was demonstrated under fed conditions. Treatment emergent adverse events were reported by 3 subjects and 1 subject following the administration of Sensityn® and the Galvusmet®, respectively. Conclusion The present findings confirmed that Sensityn®, the test medicinal product is bioequivalent to Galvusmet®, the reference medicinal product, in the rate and extent of absorption. Also, it has comparable safety profile. These findings support the continued development of vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn®) for use in patients with type 2 diabetes mellitus.