NCT07412015

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-05-27
• Primary completion: 2026-06-29
• Completion: 2026-06-29
• First posted: 2026-02-17
• Last updated: 2026-02-17