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Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

NCT07519265 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1

Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.

DRUG

Chiglitazar tablet, dose 1

Chiglitazar tablet administered as one of the reference treatment at dose level 1.

DRUG

Metformin extended-release tablet, dose 1

Metformin extended-release tablet administered as one of the reference treatment at dose level 1.

DRUG

Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2

Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.

DRUG

Chiglitazar tablet, dose 2

Chiglitazar tablet administered as one of the reference treatment at dose level 2.

DRUG

Metformin extended-release tablet, dose 2

Metformin extended-release tablet administered as one of the reference treatment at dose level 2.

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
2026-07-09
Primary Completion
2026-08-10
Completion
2026-08-10

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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 NCT07519265 on ClinicalTrials.gov