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Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects
Sponsor: The Affiliated Hospital of Qingdao University
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® XR. The study is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence crossover trial. It consists of two separate parts: a fasting study and a fed study. Participants will be randomly assigned to receive either the test formulation or the reference formulation in the first period. After a washout period of at least 5 days, participants will receive the alternate formulation in the second period. Blood samples will be collected at designated time points before and after dosing to measure the blood concentration of sitagliptin and metformin. Safety will also be continuously monitored throughout the study by assessing adverse events, vital signs, electrocardiograms (ECGs), and clinical laboratory tests.
Official title: Bioequivalence Study of Two Formulations of a Sitagliptin/Metformin Hydrochloride Extended-Release Tablet in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2023-02-14
Completion Date
2023-03-22
Last Updated
2026-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Sitagliptin / Metformin hydrochloride extended-release tablet (Test)
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., administered with 240 mL of warm water.
Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet (Janumet XR) manufactured by Merck Sharp \& Dohme Corp., administered with 240 mL of warm water.
Locations (1)
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China