drugset / Trial / NCT03791463

Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects

NCT03791463 ↗

Phase 1 Unknown 14 enrolled Peking University First Hospital
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

EvaluationDrugModalityDoseRoute
Subject salvianolic acid A Small molecule 90 mg Oral

Indications

No indication recorded.