Status:
UNKNOWN
Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Shandong Huizhi Pharmaceutical Technology Co., Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Neuropathy of Diabetes
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-...
Eligibility Criteria
Inclusion
- 1\) Gender: male or female, healthy volunteers; 2) Age: 18\~45 years old; 3) Weight: Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index \[BMI = weight (kg) / height 2 (m2)\] in the range of 19 \~ 25 kg / m2; 4) Subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
Exclusion
- (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03791125
Start Date
November 20 2018
End Date
May 20 2019
Last Update
January 2 2019
Active Locations (1)
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1
Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
Beijing, Beijing Municipality, China, 100034