KCT0007296尚未招募未知
A phase 1 study to evaluate drug-drug interactions of Bojungikgitang with Clopidogrel, Atorvastatin, and Fimasartan/Amlodipine in healthy adult volunteers
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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