NCT03791463

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	salvianolic acid A	Following an overnight fast of at least 10 hours, a single dose of 90 mg salvianolic acid A will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.

Timeline

• Start date: 2018-12-20
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2019-01-02
• Last updated: 2019-01-02

Locations

1 site across 1 country: China