Status:
UNKNOWN
Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
Lead Sponsor:
Peking University First Hospital
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 vi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03791463
Start Date
December 20 2018
End Date
January 1 2019
Last Update
January 2 2019
Active Locations (1)
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1
Xiaocong Pang
Beijing, China, 100050