JPRN-UMIN000033695已完成未知
OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF RIFAMPICIN ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B - OATP endogenous substrate-interaction study
P-One Clinic,Keikokai Medical Corp.0 个研究点目标入组 8 人开始时间: 2018年8月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 40years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1.a history of hypersensitivity to atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin 2.lactose intolerance 3.hypotension (systolic blood pressure <90 mmHg) or hypertension (systolic blood pressure >160 mmHg) 4.donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs 5.a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia 6.known to have Gilberts Disease, and/or Rotor syndrome 7.confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator 8.a clinically severe disease within 30 days before administration of study drugs 9.took drugs, health food including St. Johns wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study 10.smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period 11.took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with prohibition of taking them until the day of discharge in each study period 12.tested positive in an alcohol breath test/urine drug test at screening 13.cannot discontinue the use of drugs other than study drugs from 2 weeks before administration of study drugs until the study completion 14.positive to HBs antigens, HCV antibodies, or HIV antigens/antibodies 15.judged inappropriate by the investigator or subinvestigator
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