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

NCT07511010 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511010 on ClinicalTrials.gov