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

NCT03791463 | Unknown Phase 1

• 1 other identifier: SAA002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject

  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))

  Hour 24

Study Arms (2)

After meal

EXPERIMENTAL

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).

Drug: salvianolic acid A

Fasting

EXPERIMENTAL

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.

Drug: salvianolic acid A

Interventions

salvianolic acid A 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.

After meal; Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Xiaocong Pang

Beijing, 100050, China

RECRUITING

MeSH Terms

Interventions

salvianolic acid A

Central Study Contacts

Yimin Cui, Ph.D

CONTACT

010-66110802; cuiymzy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of pharmacy, M.D & Ph.D

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 2, 2019
• Study Start: December 20, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CN (1)