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NOT YET RECRUITING
NCT07519265
NA

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Sponsor: Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.

Official title: Bioequivalence Study of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-07-09

Completion Date

2026-08-10

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

DRUG

Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1

Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.

DRUG

Chiglitazar tablet, dose 1

Chiglitazar tablet administered as one of the reference treatment at dose level 1.

DRUG

Metformin extended-release tablet, dose 1

Metformin extended-release tablet administered as one of the reference treatment at dose level 1.

DRUG

Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2

Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.

DRUG

Chiglitazar tablet, dose 2

Chiglitazar tablet administered as one of the reference treatment at dose level 2.

DRUG

Metformin extended-release tablet, dose 2

Metformin extended-release tablet administered as one of the reference treatment at dose level 2.