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COMPLETED
NCT07679711
PHASE1

Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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