None listed
Conditions
Interventions
Drug : Banhabaekchulcheonmatang
Hanpung Banhabaekchulcheonmatang Yeonjo EX (Danmi EX combination 12 g/per sachet) will be administered orally three times a day, with two sachets per administration. T
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 H. Biopsy or major trauma within 6 months I. Bacterial endocarditis J. Esophagitis, Gastritis, or Gastroesophageal reflux within 6 months 4) Individuals with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5) Individuals whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at screening 6) AST or ALT levels that are more than double the upper limit of normal range, or total bilirubin levels that have increased by more than 1.5 times the upper limit of normal range at screening 7) Platelet count 21 units/week [1 unit = 10 mL of pure alcohol]) within 2 weeks of the first dose of this study 12) Pregnant or breastfeeding women 13) Positive result in serology tests including hepatitis B tests, human immunodeficiency virus (HIV) tests, hepatitis C tests 14) The investigator has determined that the subject is not suitable to participate in the clinical study due to other reasons, including the results of laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUClast, AUCinf, t1/2, Tmax of acetylsalicylic acid (ASA) salicylic acid (SA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Emin, percent change from baseline (CFB) of Thromboxane B2 | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Won Lee
Hanyang University Seoul Hospital
Outcome results
None listed