Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study.

ABSTRACT:

Objective

Our objective was to evaluate the pharmacokinetics and bioequivalence of test and reference (JANUMET^®) formulations of sitagliptin phosphate/metformin hydrochloride tablets at a single dose of 50 mg/850 mg.

Methods

The study was a randomized, open-label, two-period, double-crossover trial. Volunteers under fasting (n = 24) and fed (n = 24) conditions were given a single oral dose of test or reference formulations of sitagliptin phosphate/metformin hydrochloride tablets 50 mg/850 mg. We used the liquid chromatography tandem mass spectrometry method to determine the concentrations of sitagliptin and metformin in the plasma of subjects. Pharmacokinetic metrics were calculated using the WinNonlin 7.0 program, and bioequivalence was evaluated using SAS 9.4.

SUBMITTER: Shi P 

PROVIDER: S-EPMC8885939 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature