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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791463
• Other study ID #: SAA002
• Status: Recruiting
• Phase: Phase 1
• Start date: December 20, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: December 2018
• Source: Peking University First Hospital
• Contact: Yimin Cui, Ph.D
• Phone: 010-66110802
• Email: cuiymzy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Xiaocong Pang	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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