A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration
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
- Cmax
研究概览
简要总结
This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.
Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 subjects aged 18~45 (including 18 and 45 years old);
- •Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
- •Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- •The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
- •Able to comprehend and willing to sign an informed consent form.
排除标准
- •History of significant hypersensitivity to any drug compound or food；
- •Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
- •Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
- •Family history of long QTc syndrome; History or presence of an abnormal ECG；
- •Drug abusers, smokers or alcoholics；
- •Use of any medications within 14 days prior to the first administration；
- •Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
- •Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
- •Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.
研究组 & 干预措施
Group A（Dosing in the fasted state followed by fed dosing）
Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
干预措施: BPI-16350 (Drug)
Group B（Dosing in the fed state followed by fasted dosing）
Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
干预措施: BPI-16350 (Drug)
结局指标
主要结局
Cmax
时间窗: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Maximum observed concentration
AUC0-t
时间窗: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Area under the concentration-time curve from time 0 to time t
AUC0-∞
时间窗: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Area under the concentration-time curve from time 0 to infinity
次要结局
- t1/2(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- Tmax(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- λz(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- tlag(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- V/F(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- AUC %Extrap(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- CL/F(from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose)
- Characterize the safety of BPI-16350(from Day 1 to Day 23)