Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Chipscreen Biosciences

Status

Begins enrollment in 1 month

Conditions

T2DM (Type 2 Diabetes Mellitus)

Treatments

Drug: treatment R (dose 1)

Drug: treatment T (dose 1)

Drug: treatment T (dose 2)

Drug: treatment R (dose 2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07412015

CGZ113

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;
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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 4 patient groups

Treatment Sequence T-R (dose 1)

Experimental group

Description:

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.

Treatment:

Drug: treatment R (dose 1)

Drug: treatment T (dose 1)

Treatment Sequence R-T (dose 1)

Experimental group

Description:

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.

Treatment:

Drug: treatment R (dose 1)

Drug: treatment T (dose 1)

Treatment Sequence T-R (dose 2)

Experimental group

Description:

Treatment:

Drug: treatment R (dose 2)

Drug: treatment T (dose 2)

Treatment Sequence R-T (dose 2)

Experimental group

Description: