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

NCT ID: NCT03791463

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

After meal

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).

Group Type: EXPERIMENTAL

salvianolic acid A

Intervention Type: DRUG

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.

Fasting

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.

Group Type: EXPERIMENTAL

salvianolic acid A

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cui Yimin

Director of pharmacy, M.D & Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiaocong Pang

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yimin Cui, Ph.D

Role: CONTACT

cuiymzy@126.com

010-66110802

Facility Contacts

Xiaocong Pang

Role: primary

pangxiaocong1227@163.com

Other Identifiers

SAA002

Identifier Type: -

Identifier Source: org_study_id