NCT07519265

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-09
• Primary completion: 2026-08-10
• Completion: 2026-08-10
• First posted: 2026-04-09
• Last updated: 2026-04-09