A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Chipscreen Biosciences, Ltd.
- 入组人数
- 28
- 主要终点
- FE Study: Elimination Half-life （t1/2）
概览
简要总结
This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.
The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants.
The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.
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;
研究组 & 干预措施
Sequence 1 of FE study
干预措施: Chiglitazar/Metformin extended-release tablets under fasting conditions (Drug)
Sequence 1 of FE study
干预措施: Chiglitazar/Metformin extended-release tablets after a high-fat meal (Drug)
Sequence 2 of FE study
干预措施: Chiglitazar/Metformin extended-release tablets under fasting conditions (Drug)
Sequence 2 of FE study
干预措施: Chiglitazar/Metformin extended-release tablets after a high-fat meal (Drug)
multiple-dose group
干预措施: multiple-dose of Chiglitazar/Metformin extended-release tablets (Drug)
结局指标
主要结局
FE Study: Elimination Half-life （t1/2）
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Total Clearance （CL/F）
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Volume of Distribution during the terminal phase （Vz/F）
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
Multiple-dose PK study: Maximum plasma concentration (Cmax)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Time to Maximum Plasma Concentration（Tmax）
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: steady-state peak concentration (Cmax,ss)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
FE Study: Maximum plasma concentration (Cmax)
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Area Under the Plasma Concentration-Time Curve (AUC)
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Time to Maximum Plasma Concentration（Tmax）
时间窗: Pre-dose and at multiple timepoints post-dose up to 72 hours
Multiple-dose PK Study: steady-state time to peak concentration (Tmax,ss)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: under the plasma concentration-time curve at steady state (AUCss)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: trough concentration (Ctrough)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: accumulation ratio (Rac)
时间窗: predose to 72 hours after the last dose (7 consecutive days of dosing)
次要结局
- Incidence of Adverse Events (AEs)(up to Day 16)
- Change from baseline in hematology parameters: white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count , hemoglobin, hematocrit, platelet count(up to Day 13)
- Changes from baseline in serum chemistry parameters(up to Day 13)
- Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells(up to Day 13)