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NOT YET RECRUITING
NCT07412015
NA

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Sponsor: Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

Summary

This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.

Official title: Pilot 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

24

Start Date

2026-05-27

Completion Date

2026-06-29

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

DRUG

treatment T (dose 1)

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)

DRUG

treatment T (dose 2)

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)

DRUG

treatment R (dose 1)

Chiglitazar tablets and Metformin extended release tablets (dose 1)

DRUG

treatment R (dose 2)

Chiglitazar tablets and Metformin extended release tablets (dose 2)