U.S., July 2 -- ClinicalTrials.gov registry received information related to the study (NCT07679711) titled 'Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects' on June 24.
Brief Summary: The main purpose of this study is to compare the pharmacokinetics (how the body absorbs and clears the drug) and evaluate the bioequivalence of two formulations of sitagliptin/metformin hydrochloride extended-release tablets (50 mg/500 mg) in healthy adult subjects. The test product is manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., and the reference product is Janumet(R) XR.
The study is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence crossover trial. It consists o...