Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

NCT07412015 | Not Yet Recruiting

• 1 other identifier: CGZ113
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

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 (6)

• 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

• safety assessments： Incidence of Adverse Events (AEs)

  up to Day 13

Study Arms (4)

Treatment Sequence T-R (dose 1)

EXPERIMENTAL

Participants will receive treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 1 followed by treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 8.

Drug: treatment T (dose 1); Drug: treatment R (dose 1)

Treatment Sequence R-T (dose 1)

EXPERIMENTAL

Participants will receive treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 1 followed by treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 8.

Drug: treatment T (dose 1); Drug: treatment R (dose 1)

Treatment Sequence T-R (dose 2)

EXPERIMENTAL

Participants will receive treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 1 followed by treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 8.

Drug: treatment T (dose 2); Drug: treatment R (dose 2)

Treatment Sequence R-T (dose 2)

EXPERIMENTAL

Participants will receive treatment R (Chiglitazar tablets and Metformin extended-release tablets) on Day 1 followed by treatment T (Chiglitazar/Metformin extended-release fixed dose combination tablets) on Day 8.

Drug: treatment T (dose 2); Drug: treatment R (dose 2)

Interventions

treatment T (dose 1) DRUG

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)

Treatment Sequence R-T (dose 1); Treatment Sequence T-R (dose 1)

treatment T (dose 2) DRUG

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)

Treatment Sequence R-T (dose 2); Treatment Sequence T-R (dose 2)

treatment R (dose 1) DRUG

Chiglitazar tablets and Metformin extended release tablets (dose 1)

Treatment Sequence R-T (dose 1); Treatment Sequence T-R (dose 1)

treatment R (dose 2) DRUG

Chiglitazar tablets and Metformin extended release tablets (dose 2)

Treatment Sequence R-T (dose 2); Treatment Sequence T-R (dose 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: February 3, 2026
• First Posted: February 17, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share