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

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.

Inclusion Criteria:

1. 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
2. The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.

Exclusion Criteria:

1. Planned for pregnancy or pregnant within 6 months after enrollment throughout the trial.
2. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
3. Subject has a positive screening test for alcohol or drugs of abuse at screening or admission.
4. Allergic to the body.
5. Participated in any clinical trial within 3 months prior to the trial.