A phase 1 study to evaluate drug-drug interactions of Bojungikgitang with Clopidogrel, Atorvastatin, and Fimasartan/Amlodipine in healthy adult volunteers
- Conditions
- Not Applicable
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 42
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
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 <60 mL/min/1.73m2
C.Positive in hepatitis B virus surface antigen, antibodies against hepatitis C and human immunodeficiency virus, and syphilis reagin test
D.Systolic blood pressure >150 mmHg or <90 mmHg, or diastolic blood pressure >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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Evaluation of safety - vital sign, 12 lead electrocardiogram, clinical laboratory tests (common blood counts, biochemistry, urine analysis), physical exam, adverse events