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(R)) and Galvusmet(R)50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions
Abstrakt
Vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn(R)) 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(R) Film Coated Tablets (Test Product/Alpha Pharma Industries, a subsidiary of Cigalah Healthcare LLC, KAEC, Saudi Arabia) and Galvusmet(R) Film Coated Tablets (Reference product/Novartis Pharma, Switzerland), in healthy adults under fed conditions.
Safety and tolerance were evaluated as secondary endpoints. 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(R)) or the reference medicinal product (Galvusmet(R)); 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-oo and for untransformed data for Tmax, Kelimination (λz) and half-life. The results showed that Cmax, AUC0-t, and AUC0-oo have passed the 90% CI acceptance limits of 80.00%-125.00% for vildagliptin and metformin.
Consequently, the bioequivalence of Sensityn(R) and Galvusmet(R) 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(R) and the Galvusmet(R), respectively.
The present findings confirmed that Sensityn(R), the test medicinal product is bioequivalent to Galvusmet(R), 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(R)) for use in patients with type 2 diabetes mellitus.