临床试验/NCT07412015

NCT07412015尚未招募不适用

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

Chipscreen Biosciences, Ltd.0 个研究点目标入组 24 人开始时间: 2026年5月27日最近更新: 2026年2月17日

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 24
主要终点: Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

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.

干预措施: treatment T (dose 1) (Drug)

Treatment Sequence T-R (dose 1)

Experimental

干预措施: treatment R (dose 1) (Drug)

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.

干预措施: treatment T (dose 1) (Drug)

Treatment Sequence R-T (dose 1)

Experimental

干预措施: treatment R (dose 1) (Drug)

Treatment Sequence T-R (dose 2)

Experimental

干预措施: treatment T (dose 2) (Drug)

Treatment Sequence T-R (dose 2)

Experimental

干预措施: treatment R (dose 2) (Drug)

Treatment Sequence R-T (dose 2)

Experimental

干预措施: treatment T (dose 2) (Drug)

Treatment Sequence R-T (dose 2)

Experimental

干预措施: treatment R (dose 2) (Drug)

结局指标

主要结局

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

时间窗: 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-∞)

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

Maximum plasma concentration (Cmax)

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

次要结局

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)

研究者

发起方

Chipscreen Biosciences, Ltd.

申办方类型

Industry

责任方

Sponsor

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