A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.
详细描述
This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.
For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject,18-45 years of age.
- •BMI between 19 and 26; Weight between 50 and 80 kg.
- •Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.
- •Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.
- •Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.
排除标准
- •Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.
- •History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.
- •Addicted to smoking and drinking in 3 months before the trial.
- •Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.
- •Other conditions not suitable for trial, by judgement of investigator.
研究组 & 干预措施
SHC014748M: Fast + Fed
Participants will receive a single oral dose of SHC014748M capsules in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fed condition on Day 8 of treatment period 2.
干预措施: SHC014748M Capsules (Drug)
SHC014748M: Fed + Fast
Participants will receive a single oral dose of SHC014748M capsules in fed condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fasted condition on Day 8 of treatment period 2.
干预措施: SHC014748M Capsules (Drug)
结局指标
主要结局
Cmax
时间窗: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration
AUC(0-∞)
时间窗: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity
AUC(0-t)
时间窗: 72 hours
Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.
次要结局
- t l/2(72 hours)
- CL/F(72 hours)
- tmax(72 hours)
- AUC[%Extrap obs](72 hours)
- λz(72 hours)
- Vz/F(72 hours)
- MRT(72 hours)