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Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects

Healthy Subjects Clinical Trial

Official title:
Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study

Clinical Trial Summary

An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition) to assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets.

Clinical Trial Description

The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. This study was conducted to assess the bioequivalence of Sitagliptin Phosphate/metformin Hydrochloride Tablets in healthy Chinese subjects and estimate the pharmacokinetics profiles of Sitagliptin Phosphate/metformin Hydrochloride Tablets. An open-label, randomized, single-dose, two-period, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 subjects for each condition) to assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets. Blood samples were collected at specified time intervals, and the plasma concentrations of sitagliptin and metformin were determined by a validated liquid chromatography mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability parameters were estimated via non-compartmental methods. Adverse events were also recorded. If the 90% confidence intervals of the ratios of geometrical mean of test and reference formulations for Cmax, AUC0-t and AUC0-∞ are all within the predefined bioequivalence criteria range of 80%-125% for sitagliptin and metformin, the two formulations can be considered bioequivalent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04877106
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact
Status Completed
Phase Phase 1
Start date April 7, 2018
Completion date July 31, 2018
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