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

NCT07679711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical (Hainan) Co., Ltd.

    collaborator INDUSTRY

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-03-22
Completion
2023-03-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679711 on ClinicalTrials.gov