None listed
Conditions
Interventions
Drug : Part 1: Clopidogrel will be administered repeatedly for 4 days. After repeated administration of Bojungikgi-tang for 10 days, it will be administered in combination with clopidogrel for 4 days.
Sponsors
Kyunghee University-industry Cooperation Foundation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) A person who voluntarily signed an informed consent form after hearing a sufficient explanation about the purpose and content of the trial and characteristics of study drugs 2) Healthy men aged =19 years 3) A body weight of =50 kg and a body mass index of =18.0 kg/m2 to =30.0 kg/m2
Exclusion criteria
Exclusion criteria: 1. Clinically significant history of liver; kidney; and digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, hematological, oncological, and cardiovascular (including orthostatic hypotension) systems 2. History of gastrointestinal diseases or surgery that can affect the absorption of study drugs (e.g., Crohn's disease, esophageal diseases such as esophageal achalasia or esophageal stenosis). Appendectomy, hernia surgery, intraoperative endoscopic polypectomy, and surgery for hemorrhoids, anal fissure, and anal fistula are excluded. 3. Clinically significant history of hypersensitive reaction, intolerance, and anaphylactic shock to active pharmaceutical ingredients and excipients of study drugs and dihydropyridine derivatives 4. Bleeding (peptic ulcer, intracranial hemorrhage, hemophilia, gastrointestinal and urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.) 5. Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 6. Findings as follows: A. Increased serum alanine and aspartate aminotransferase, total bilirubin, and creatine kinase levels =2x upper limit of normal in a laboratory test B. Estimated glomerular filtration rate 150 mmHg or 100 mmHg or <50 mmHg measured after a 3-min rest in a sitting position 7. Clinically significant abnormal results at screening (findings other than those mentioned in criteria number 6) 8. A person who has administered any prescription drugs, herbal medicinal preparations, over the counter drugs, or vitamin preparations within 2 weeks; or who do not agree to the prohibition of their administration. However, he may participate if it is considered that the administration does not affect his safety and study results according to the investigator’s judgment. 9. Administration of other investigational drugs within 180 days before the first administration of the study drug 10. Presence or history of drug abuse (especially central nervous system drugs such as sleeping pills, centrally acting analgesics, opiates, or psychotropic drugs) 11. Continuous alcohol consumption more than 21 units a week within 6 months of screening 12. Smoking exceeding 5 cigarettes per day within 6 months of screening 13. A person who donated whole blood within 8 weeks or blood components (plasma, platelets) within 4 weeks before the first administration of the study drugs; or who do not agree to the prohibition of blood donation within 30 days after the last administration 14. A person who does not agree to discontinue diet that can affect absorption, distribution, metabolism, and excretion of the study drugs (especially grapefruit juice, caffeine, nicotine) from 3 days before the first administration of the study drugs to the last visit 15. A person who does not agree to use contraceptive methods by the person himself or his female partner from the time of administration of study drugs to at least 15 days from the last dose 16. Unsuitability for study participation according to the investigator’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, ss, AUCt, ss, Tmax, ss etc. of clopidogrel;Cmax, ss, AUCt, ss, Tmax, ss etc. of atorvastatin;Cmax, ss, AUCt, ss, Tmax, ss etc. of fimasartan / amlodipine;Cmax, ss, AUCt, ss, Tmax, ss etc. of Ginsenoside Rb1, glycyrrhizic acid, hesperidin and other analyzable ingredients;(Part 1 - Clopidogrel) Inhibition of platelet aggregation (%);(Part 2 - Atorvastatin) Total cholesterol, LDL cholesterol, Triglyceride;(Part 3 - Fimasartan / amlodipine) Blood pressure, serum aldosterone level | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety - vital sign, 12 lead electrocardiogram, clinical laboratory tests (common blood counts, biochemistry, urine analysis), physical exam, adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungwon Kwon
Kyung Hee University Oriental Medical Center
Outcome results
None listed