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

P

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

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

Exclusion criteria

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

Trial design

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

Trial contacts and locations

0

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Central trial contact

Yimin Cui, Ph.D

Data sourced from clinicaltrials.gov

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