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

Phase 1

• Conditions: Healthy
• Interventions: Drug: salvianolic acid A

• Registration Number: NCT03791463
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-20
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-28
• Last Update Submitted: 2018-12-28
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Study First Posted: 2019-01-02
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasting	salvianolic acid A	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.
After meal	salvianolic acid A	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).

Primary Outcome Measures

Name	Time	Method
The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject	Hour 24	To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last))

Trial Locations

Locations (1)

Xiaocong Pang; 🇨🇳 Beijing, China