Clinical Research Directory

Bioequivalence of Sitagliptin/Metformin Tablets in Healthy Chinese Adults Under Fasting and Fed Conditions

Sponsor: Guangzhou Panyu Central Hospital

Summary

This study evaluated whether a test formulation of sitagliptin/metformin tablets (manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd.) is bioequivalent to the reference product Janumet (sitagliptin phosphate/metformin hydrochloride tablets, MSD) in healthy Chinese adults. The study was conducted as two independent cohorts (fasting and fed) at a single centre. Each cohort used a randomised, open-label, two-period, two-sequence, single-dose crossover design with a 7-day washout between periods, and 28 subjects were enrolled in each cohort. In each period, subjects received a single oral dose of the test or the reference product, and serial blood samples were collected up to 48 hours after dosing to determine plasma sitagliptin and metformin concentrations with a validated analytical method. The primary pharmacokinetic parameters were Cmax, AUC0-t and AUC0-inf. Bioequivalence was to be concluded if the 90% confidence intervals of the geometric mean ratios (test/reference) for these parameters fell within the predefined acceptance range of 80.00%-125.00%. Safety was assessed throughout the study.

Official title: A Single-Centre, Randomised, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Bioequivalence of Sitagliptin/Metformin Hydrochloride Tablets (50 mg/850 mg) in Healthy Chinese Subjects Under Fasting and Fed Conditions

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