T2DM (Type 2 Diabetes Mellitus)
Conditions
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.
Interventions
DRUGtreatment T (dose 1)
Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)
DRUGtreatment T (dose 2)
Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)
DRUGtreatment R (dose 1)
Chiglitazar tablets and Metformin extended release tablets (dose 1)
DRUGtreatment R (dose 2)
Chiglitazar tablets and Metformin extended release tablets (dose 2)
Sponsors
Chipscreen Biosciences, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Changes from baseline in laboratory safety parameters （including hematology, serum chemistry, coagulation, and urinalysis） | up to Day 11 |
Outcome results
None listed