Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

April 7, 2026 updated by: Chipscreen Biosciences, Ltd.

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male or female participants；
  • Age from 18 to 45 years, inclusive；
  • Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；
  • From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；
  • Voluntarily agrees to participate in the study and signs the informed consent form.

Exclusion Criteria:

  • Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine/metabolic disorders;
  • Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;
  • Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;
  • Surgery within 3 months prior to screening or planned surgery during the study period;
  • Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;
  • History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;
  • Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;
  • Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;
  • History of drug or substance abuse, or a positive alcohol or urine drug screening test;
  • Intolerance to venipuncture, or a history of fainting in response to needles or blood;
  • Fasting blood glucose > 6.1 mmol/L or < 3.9 mmol/L at screening, and/or a history of hypoglycemia/syncope;
  • Participation in any interventional clinical trial within 3 months prior to screening;
  • Blood donation or significant blood loss (> 200 mL) within 3 months prior to screening;
  • Pregnant or lactating women;
  • Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;
  • Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;
  • Excessive daily consumption of tea, coffee, and/or caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;
  • Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;
  • Glomerular Filtration Rate (GFR) < 90 mL/min/1.73 m²;
  • Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure < 50 mmHg or ≥ 90 mmHg at screening;
  • A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;
  • Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;
  • Plans to or is required to engage in strenuous physical activity or exercise during the study period;
  • Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence T-R (dose 1)
Participants will receive Chiglitazar/Metformin extended-release fixed dose combination tablets at dose level 1 in Period 1 on Day 1, followed by Chiglitazar tablets and Metformin extended-release tablets at dose level 1 in Period 2 on Day 1.
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.
Experimental: Sequence R-T (dose 1)
Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 1 in Period 1 on Day 1, followed by chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 1 in Period 2 on Day 1.
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.
Experimental: Sequence T-R (dose 2)
Participants receive chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 2 on Day 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.
Experimental: Sequence R-T (dose 2)
Participants receive chiglitazar tablet and metformin extended-release tablet at dose level 2 in Period 1 on Day 1, followed by chiglitazar/metformin extended-release fixed-dose combination tablet at dose level 2 in Period 2 on Day 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Maximum Plasma Concentration（Tmax）
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Elimination Half-life （t1/2）
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Total Clearance （CL/F）
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Volume of Distribution during the terminal phase （Vz/F）
Time Frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Pre-dose and at multiple timepoints post-dose up to 72 hours
Incidence of Adverse Events (AEs)
Time Frame: up to Day 11
up to Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chipscreen Biosciences, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 9, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGZ112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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