Bioequivalence study of different brands of vildagliptin in healthy human subjects

Abstract Background Vildagliptin is a dipeptidyl peptidase-4 inhibitor used to treat diabetes mellitus. No bioequivalence study data have been published for the Indian population comparing of vildagliptin brands Galvus, Zomelis, and Jalra. This aimed evaluate between three 50 mg tablet (test 1, Zomelis; test 2, Jalra; reference, Galvus) compare these formulations with reference formulation meet regulatory requirements CDSCO, India. The was conducted in clinical research center college after enrolling 12 healthy volunteers. single-dose, randomized, open-label, balanced, treatment, period, under fasting condition adult After overnight fasting, subjects received single dose either any (T1—test 1; T2—test 2; R—reference). washout period 7 days. Randomization way T1T2R first T2T1R second RT1T2 third period. Blood samples were collected, that drug concentration plasma measured help HPLC. Outcome measures 90% confidence interval geometric mean ratios (test/reference) LnC max , LnAUC0-t, LnAUC0-? calculated. Results AUC0-t 1390.03, 1401.50, 1409.37 ng h/ml T1, T2, R, respectively. C 287.89, 287.41, 285.17 ng/ml AUC0-? 1452.03, 1467.59, 1473.53 significant difference observed pharmacokinetic parameters R. T1/R 1.0014 (90% CI, 1.0002–1.0026), 0.9992 0.9971–1.0013), 0.9994 0.9973–1.0016), For T2/R, 1.0003 0.9992–1.0013), 0.9988 0.9969–1.0008), 0.9985 0.9961–1.0010), Conclusion In this single-dose involving volunteers conditions, (Zomelis, Jalra, bioequivalent as per criterion