drugset / Trial / NCT07511010

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

NCT07511010

Phase 1 Not yet recruiting 28 enrolled Chipscreen Biosciences, Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2026-10-08
Primary completion
2026-10-26
Completion
2026-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Chiglitazar Unknown Oral
Subject Metformin Small molecule Oral