Not Yet RecruitingNot Applicable

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

64 participantsStarted 2026-07-09

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 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-∞)

Timeframe: Pre-dose and at multiple timepoints post-dose up to 72 hours

Trial details

NCT IDNCT07519265

SponsorChipscreen Biosciences, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-10

View on ClinicalTrials.gov More T2DM (Type 2 Diabetes Mellitus) trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 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-∞)

Timeframe: Pre-dose and at multiple timepoints post-dose up to 72 hours