NCT07511010

Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release Tablets

A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study. The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants. The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	Chiglitazar/Metformin extended-release tablets under fasting conditions	a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions
DRUG	Chiglitazar/Metformin extended-release tablets after a high-fat meal	a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal
DRUG	multiple-dose of Chiglitazar/Metformin extended-release tablets	a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10

Timeline

• Start date: 2026-10-08
• Primary completion: 2026-10-26
• Completion: 2026-10-26
• First posted: 2026-04-06
• Last updated: 2026-04-06