T2DM (Type 2 Diabetes Mellitus)NCT07519265
Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
A study testing Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1 and Metformin extended-release tablet, dose 1 in people with T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial 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. 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?
- Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1 and Metformin extended-release tablet, dose 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to 3 Aug 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 < 50 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
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 101300
About this study
Official title: 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 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.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1, Metformin extended-release tablet, dose 1, Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2, Chiglitazar tablet, 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.
Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1Drug
Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1.
Chiglitazar tablet, dose 1Drug
Chiglitazar tablet administered as one of the reference treatment at dose level 1.
Metformin extended-release tablet, dose 1Drug
Metformin extended-release tablet administered as one of the reference treatment at dose level 1.
Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2Drug
Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2.
Chiglitazar tablet, dose 2Drug
Chiglitazar tablet administered as one of the reference treatment at dose level 2.
Metformin extended-release tablet, dose 2Drug
Metformin extended-release tablet administered as one of the reference treatment at dose level 2.
| Study group | Role | What they receive |
|---|---|---|
| Sequence T-R (dose 1) | Experimental | Participants 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. Receives: Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1; Drug: Chiglitazar tablet, dose 1; Drug: Metformin extended-release tablet, dose 1 |
| Sequence R-T (dose 1) | Experimental | Participants 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. Receives: Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1; Drug: Chiglitazar tablet, dose 1; Drug: Metformin extended-release tablet, dose 1 |
| Sequence T-R (dose 2) | Experimental | Participants 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. Receives: Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2; Drug: Chiglitazar tablet, dose 2; Drug: Metformin extended-release tablet, dose 2 |
| Sequence R-T (dose 2) | Experimental | Participants 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. Receives: Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2; Drug: Chiglitazar tablet, dose 2; Drug: Metformin extended-release tablet, dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 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)
Measured: 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-∞)
Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours
Secondary outcomes (5)
Time to Maximum Plasma Concentration（Tmax）
Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours
Elimination Half-life （t1/2）
Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Total Clearance （CL/F）
Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Volume of Distribution during the terminal phase （Vz/F）
Measured: Pre-dose and at multiple timepoints post-dose up to 72 hours
Incidence of Adverse Events (AEs)
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.
- First posted9 Apr 2026
- Study start9 Jul 2026
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519265
- Sponsor's protocol ID
- CGZ112
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07519265
- Acronym / sponsor ID
- CGZ112
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence T-R (dose 1) | Experimental | Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Drug: Chiglitazar tablet, dose 1, Drug: Metformin extended-release tablet, dose 1Participants 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) | Experimental | Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Drug: Chiglitazar tablet, dose 1, Drug: Metformin extended-release tablet, dose 1Participants 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) | Experimental | Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2, Drug: Chiglitazar tablet, dose 2, Drug: Metformin extended-release tablet, dose 2Participants 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) | Experimental | Drug: Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2, Drug: Chiglitazar tablet, dose 2, Drug: Metformin extended-release tablet, dose 2Participants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 1. | Drug | Sequence R-T (dose 1), Sequence T-R (dose 1) |
| Chiglitazar tablet, dose 1Chiglitazar tablet administered as one of the reference treatment at dose level 1. | Drug | Sequence R-T (dose 1), Sequence T-R (dose 1) |
| Metformin extended-release tablet, dose 1Metformin extended-release tablet administered as one of the reference treatment at dose level 1. | Drug | Sequence R-T (dose 1), Sequence T-R (dose 1) |
| Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2Fixed-dose combination tablet containing chiglitazar and metformin extended-release, administered at dose level 2. | Drug | Sequence R-T (dose 2), Sequence T-R (dose 2) |
| Chiglitazar tablet, dose 2Chiglitazar tablet administered as one of the reference treatment at dose level 2. | Drug | Sequence R-T (dose 2), Sequence T-R (dose 2) |
| Metformin extended-release tablet, dose 2Metformin extended-release tablet administered as one of the reference treatment at dose level 2. | Drug | Sequence R-T (dose 2), Sequence T-R (dose 2) |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 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-∞)
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
5 secondary outcomes
Time to Maximum Plasma Concentration（Tmax）
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Elimination Half-life （t1/2）
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Total Clearance （CL/F）
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Apparent Volume of Distribution during the terminal phase （Vz/F）
Time frame: Pre-dose and at multiple timepoints post-dose up to 72 hours
Incidence of Adverse Events (AEs)
Time frame: up to Day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1 and Metformin extended-release tablet, 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?
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.