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Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Pilot 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

NCT07412015•Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

Summary

This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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;
+14 more criteria

Key Dates

Start Date

May 27, 2026

Primary Completion Date

June 29, 2026

Completion Date

June 29, 2026

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

treatment T (dose 1)

DRUG

treatment T (dose 2)

DRUG

treatment R (dose 1)

DRUG

treatment R (dose 2)

DRUG

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus

NCT07321678

T2DM (Type 2 Diabetes Mellitus)

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RECRUITINGNA

To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

NCT06293417

T2DM (Type 2 Diabetes Mellitus)Dyslipidemias

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Inclusion Criteria

Exclusion Criteria

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