drugset / Trial / NCT03791463
Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-12-20
- Primary completion
- 2019-01-01
- Completion
- 2019-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | salvianolic acid A | Small molecule | 90 mg | Oral |
Indications
No indication recorded.