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T2DM (Type 2 Diabetes Mellitus)NCT07412015

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

A study testing treatment T (dose 1), treatment T (dose 2) and treatment R (dose 1) in people with T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
treatment T (dose 1), treatment T (dose 2) and treatment R (dose 1)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
15 May 2026to 28 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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 < 60 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Institute of Schistosomiasis Control (Hunan Provincial Third People's Hospital)

    Yueyang, Hunan, 414000

Other trials in China

About this study

Official title: 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

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.

Being tested
treatment T (dose 1), treatment T (dose 2), treatment R (dose 1), treatment R (dose 2)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment T (dose 1)Drug

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

  • treatment T (dose 2)Drug

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

  • treatment R (dose 1)Drug

    Chiglitazar tablets and Metformin extended release tablets (dose 1)

  • treatment R (dose 2)Drug

    Chiglitazar tablets and Metformin extended release tablets (dose 2)

Study groups in NCT07412015
Study groupRoleWhat they receive
Treatment Sequence T-R (dose 1)ExperimentalParticipants 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.
Receives: Drug: treatment T (dose 1); Drug: treatment R (dose 1)
Treatment Sequence R-T (dose 1)ExperimentalParticipants 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.
Receives: Drug: treatment T (dose 1); Drug: treatment R (dose 1)
Treatment Sequence T-R (dose 2)ExperimentalParticipants 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.
Receives: Drug: treatment T (dose 2); Drug: treatment R (dose 2)
Treatment Sequence R-T (dose 2)ExperimentalParticipants 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.
Receives: Drug: treatment T (dose 2); Drug: treatment R (dose 2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum plasma concentration (Cmax)

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

  2. Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)

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

  3. Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)

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

Secondary outcomes (6)

  1. Time to Maximum Plasma Concentration（Tmax）

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

  2. Elimination Half-life （t1/2）

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

  3. Apparent Total Clearance （CL/F）

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

  4. Apparent Volume of Distribution during the terminal phase （Vz/F）

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

  5. safety assessments： Incidence of Adverse Events (AEs)

    Measured: up to Day 13

  6. Changes from baseline in laboratory safety parameters （including hematology, serum chemistry, coagulation, and urinalysis）

    Measured: up to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start15 May 2026
  3. Primary completion26 May 2026
  4. Study completion28 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412015
Sponsor's protocol ID
CGZ113
Status last verified
Jun 2026
First submitted
3 Feb 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing treatment T (dose 1), treatment T (dose 2) and treatment R (dose 1) in people with T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum plasma concentration (Cmax) (time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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