A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- maximum concentrations (Cmax ) for plasma
研究概览
简要总结
This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
- •healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- •body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 26 kg/m2 (including cut-off value).
排除标准
- •have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
- •hepatitis B surface antigen HBsAg positive.
- •hepatitis C virus antibody positive.
- •positive AIDS antigen/antibody or Treponema pallidum antibody
研究组 & 干预措施
IBI351
This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects. In a double-crossover design, subjects were enrolled and randomly divided into two test groups A and B. Group A: IBI351 was orally administered to subjects in this group on an empty stomach on Day 1, followed by a high-fat meal on Day 4. Group B: IBI351 was orally administered to subjects in this group after a high-fat meal on Day 1 followed by an empty stomach on Day 4.
干预措施: IBI351 (Drug)
IBI351+Esomeprazole
Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
干预措施: IBI351 (Drug)
IBI351+Esomeprazole
Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
干预措施: Esomeprazole (Drug)
结局指标
主要结局
maximum concentrations (Cmax ) for plasma
时间窗: approximately 10 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
时间窗: approximately 10 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
时间窗: approximately 10 days after first dose
次要结局
- number of participants with abnormal ECG readings(approximately 10 days after first dose)
- number of participants with abnormal hematology test results(approximately 10 days after first dose)
- number of participants with abnormal chemisty test results(approximately 10 days after first dose)
- number of participants with abnormal vital signs(approximately 10 days after first dose)
- time-to-maximum concentration (Tmax) for total plasma(approximately 10 days after first dose)
- half-life (t1/2) for total plasma(approximately 10 days after first dose)
- apparent clearance (CL/F) for total plasma(approximately 10 days after first dose)
- the time prior to the first measurable (non-zero) concentration （tlag）(approximately 10 days after first dose)
- apparent volume of distribution(Vz/F) for total plasma(approximately 10 days after first dose)
- adverse events(approximately 10 days after first dose)
- number of participants with abnormal physical examination(approximately 10 days after first dose)