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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03791463

Enrollment

Registered

2019-01-02

Start date

2018-12-20

Completion date

2019-01-01

Last updated

2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGsalvianolic 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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))

Countries

China

Contacts

Primary ContactYimin Cui, Ph.D

cuiymzy@126.com010-66110802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026