A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject
研究概览
简要总结
This study is an open-label, randomized, cross-over design with two single-dose treatment periods and a washout of at least 3~5 days in between each treatment visit. The study period consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment).
Target subject population is healthy subjects aged 18-45 years. Following an overnight fast of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
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
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19.0 and ≤25.0 kg/m2 at screening
- •The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
排除标准
- •Planned for pregnancy or pregnant within 6 months after enrollment throughout the trial.
- •Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
- •Subject has a positive screening test for alcohol or drugs of abuse at screening or admission.
- •Allergic to the body.
- •Participated in any clinical trial within 3 months prior to the trial.
研究组 & 干预措施
After meal
Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
干预措施: salvianolic acid A (Drug)
Fasting
Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered at the end of a 10-hour fast.
干预措施: salvianolic acid A (Drug)
结局指标
主要结局
The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject
时间窗: Hour 24
To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last))
次要结局
未报告次要终点
研究者
Cui Yimin
Director of pharmacy, M.D & Ph.D
Peking University First Hospital