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

Peking University

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: salvianolic acid A

Study type: Interventional

Funder types: Other

Identifiers

NCT03791463

SAA002

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

After meal

Experimental group

Description:

Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).

Treatment:

Drug: salvianolic acid A

Fasting

Experimental group

Description:

Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered at the end of a 10-hour fast.

Treatment:

Drug: salvianolic acid A