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NOT YET RECRUITING
NCT07511010
PHASE1

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

Sponsor: Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-10-08

Completion Date

2026-10-26

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

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