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

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03791463
Study type Interventional
Source Peking University First Hospital
Contact Yimin Cui, Ph.D
Phone 010-66110802
Email cuiymzy@126.com
Status Recruiting
Phase Phase 1
Start date December 20, 2018
Completion date January 1, 2019
View Details
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