to Evaluate the Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma area under curve（AUC）(0-∞) of SPH3127 3127
研究概览
简要总结
This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets.
Two panels, each consisting of ten participants (The number of single-sex subjects is not less than 1/3 of the total number) will be randomized to A or B groups.
详细描述
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The body mass index is 19 ~ 26kg/m2 (including the critical value), which allows the minimum weight of male to be 50kg (including the critical value) and 45kg (the critical value) for women.
- •Before the study, participants have kown about the significance, potential benefits, inconveniences and potential risks of the study and can follow the research's procedure and already sign the informed consent
排除标准
- •Participant who pregnancy, lactating women, and plan to get pregnant within six months after the clinical trial
- •Participant who has significant abnormal physical examination, laboratory examination results (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
- •Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
- •Participant who has drug allergy history, allergy constitution
- •Participant who took oral contraceptives within 6 weeks
- •Participant who used any drug (including Chinese herbal medicine) within 1 week
- •Participant who donated blood within 2 months
- •Participant who participated clinical trials of any drug in the past 3 months (as subjects)
- •Participant who has any positive result of virus serology check : human immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) - Immunoglobulin G（IgG)antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP)
- •Participant who are smoking, drinking, drinking coffee, strong tea and drug abusers
- •Participant who the researchers believe that there are volunteers who are not suitable for the study
研究组 & 干预措施
SPH3127 200mg Panel A
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
干预措施: SPH3127 200mg Panel A (Drug)
SPH3127 200mg Panel B
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
干预措施: SPH3127 200mg Panel B (Drug)
结局指标
主要结局
Plasma area under curve（AUC）(0-∞) of SPH3127 3127
时间窗: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding
Apparent terminal half-life of SPH3127
时间窗: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Apparent terminal half-life of SPH3127 by feeding
Plasma Cmax of SPH3127
时间窗: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Cmax of SPH3127 by feeding
Plasma Tmax of SPH3127
时间窗: Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose
to evaluate the Tmax of SPH3127 by feeding
次要结局
- Change from baseline in laboratory hematology values(Baseline to 10-13 days post last dose)
- Change from baseline in ECG(Baseline to 10-13 days post last dose)
- Change from baseline in laboratory chemistry values(Baseline to 10-13 days post last dose)
- Number of participants with adverse events (AEs)(Baseline to 10-13 days post last dose)