KCT0008365
Not yet recruiting
未知
An exploratory clinical trial to evaluate the effect of Banhabaekchulcheonmatang and Hwangryeonhaedoktang on the pharmacokinetics and pharmacodynamics of aspirin in healthy adults
Hanyang University Seoul Hospital0 sites14 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hanyang University Seoul Hospital
- Enrollment
- 14
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adults aged 19 to 50 years of age (inclusive) at the time of screening
- •2\) BMI of 18 to 32 kg/m2 (inclusive)
- •3\) Agree to use medically acceptable methods of contraception by participant, and not to donate sperm or oocyte
- •4\) Voluntarily decided to participate in the study and provided written consent to comply with the protocol
Exclusion Criteria
- •1\) Current or history of a clinically significant cardiovascular, respiratory, hepatic, renal, hemato\-oncological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
- •2\) History of hypersensitivity reactions that are clinically significant or hypersensitivity reactions to the components or constituents of the investigational product
- •3\) Who has clinically significant hemorrhage or an increased risk of hemorrhage due to the following conditions
- •A. Stomach ulcers within 6 months
- •B. Malignant tumor with a high risk of bleeding
- •C. Brain or spinal cord injury or surgery
- •D. Opthalmic surgery within 6 months
- •E. History of intracranial or intracerebral hemorrhage
- •F. Esophageal varices, arterial malformations, vascular aneurysms, or spinal cord or cerebral vascular abnormalities
- •G. Coagulation disorders, thrombocytopenia, or platelet dysfunction
Outcomes
Primary Outcomes
Not specified
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