NCT07024888已完成1 期
Effect of Food on the Pharmacokinetics of SSS17 Capsules: A Study in Chinese Healthy Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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 adult subjects aged 18 to 45 years
- •Good health status with no clinically significant medical history.
- •Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
- •Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up
排除标准
- •Hypersensitivity to investigational drug/excipients.
- •Dysphagia, GI disorders affecting absorption, or relevant surgery history .
- •Intolerance to venipuncture or needle/blood phobia.
- •Clinically significant disorders affecting drug ADME.
- •Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
- •Family history of malignancy or major surgery within 3 months pre-screening.
- •Participation in other drug/device trials with investigational product use within 3 months.
- •Blood donation/loss within 3 months.
- •Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME.
- •Any medication use within 14 days pre-dosing.
- •Regular alcohol >14 units/week within 3 months.
- •Smoking >5 cigarettes/day within 3 months or unwilling to abstain during trial.
- •Caffeine products within 48h pre-dosing.
- •Alcohol consumption within 48h or positive alcohol screen.
- •Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis.
- •Pregnancy/lactation or unprotected sex
- •Positive drug screen, drug abuse history, or drug use within 3 months.
- •Any condition compromising safety/compliance, or investigator's judgment of unsuitability
研究组 & 干预措施
Fasting Group
Other
干预措施: SSS17 (Drug)
Low-fat Meal Concomitant Administration Group
Other
干预措施: SSS17 (Drug)
High-fat Meal 2-Hour Post-dose Group
Other
干预措施: SSS17 (Drug)
结局指标
主要结局
Cmax
时间窗: Day1 to Day73
AUC
时间窗: Day 1 to Day 73
次要结局
- Tmax(Day1 to Day73)
- t1/2(Day 1 to Day 73)
- CL/F(Day 1 to Day 73)
- AEs(up to Day 73)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy SubjectsLocally Advanced or Metastatic NSCLCNCT04360915Jiangsu Aosaikang Pharmaceutical Co., Ltd.24
已完成
1 期
The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult SubjectsHealthyNCT01905553Shire9
进行中（未招募）
1 期
Effect of food on the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients treated with saquinavir/ritonavir 1000/100 mg b.i.d. - Saquinavir food pharmacokinetic studyEUCTR2005-004430-41-GBSt Stephen's AIDS Trust24
已完成
1 期
评估在健康人中食物对 SSS17 胶囊药代动力学影响 I 期试验CTR2025059436
已完成
1 期
Effect of Food on BIA 6-512 (Trans-resveratrol)Parkinson DiseaseNCT03095092Bial - Portela C S.A.24