Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
1 other identifier
interventional
64
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
July 9, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2026
Study Completion
Last participant's last visit for all outcomes
August 10, 2026
April 9, 2026
March 1, 2026
1 month
March 20, 2026
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum plasma concentration (Cmax)
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)
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-∞)
Pre-dose and at multiple timepoints post-dose up to 72 hours
Secondary Outcomes (5)
Time to Maximum Plasma Concentration（Tmax）
Pre-dose and at multiple timepoints post-dose up to 72 hours
Elimination Half-life （t1/2）
Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Total Clearance （CL/F）
Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Volume of Distribution during the terminal phase （Vz/F）
Pre-dose and at multiple timepoints post-dose up to 72 hours
Incidence of Adverse Events (AEs)
up to Day 11
Study Arms (4)
Sequence T-R (dose 1)
EXPERIMENTALParticipants 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.
Sequence R-T (dose 1)
EXPERIMENTALParticipants 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.
Sequence T-R (dose 2)
EXPERIMENTALParticipants 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.
Sequence R-T (dose 2)
EXPERIMENTALParticipants 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.
Interventions
Chiglitazar tablet administered as one of the reference treatment at dose level 1.
Metformin extended-release tablet administered as one of the reference treatment at dose level 1.
Chiglitazar tablet administered as one of the reference treatment at dose level 2.
Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.
Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.
Metformin extended-release tablet administered as one of the reference treatment at dose level 2.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2026
First Posted
April 9, 2026
Study Start (Estimated)
July 9, 2026
Primary Completion (Estimated)
August 10, 2026
Study Completion (Estimated)
August 10, 2026
Last Updated
April 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share