KCT0007296
Not yet recruiting
未知
A phase 1 study to evaluate drug-drug interactions of Bojungikgitang with Clopidogrel, Atorvastatin, and Fimasartan/Amlodipine in healthy adult volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyunghee University-industry Cooperation Foundation
- Enrollment
- 42
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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