Study for drug-drug interactions involving hepatic OATPs using its endogenous substrates - 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: 2017年8月16日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 8

研究概览入排标准研究者记录与标识符相似试验

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

•a) Subjects who have any hypersensitivity to atorvastatin, fluvastatin, pitavasitatin, rosuvastatin, and rifampicin. b) Subjects who is suffering from acute narrow-angle glaucoma. c) Subjects who is suffering from hypotension( systolic blood pressure < 100mmHg ), hypertension (systolic blood pressure > 140mmHg), diabetes and anemia ( Hb < 12.0g/dL ) at the timing of the screening. d) Subjects who donated or lost over 200 mL (1 unit ) of blood in the past 4weeks or over 400mL (2 units) of blood in the past 3months. e) Subjects who suffer/suffered from severe nervous disease, celebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including disease which is expected to affect the absorption of test drugs), respiratory disease and metabolic disease. f) Subjects who is confirmed to have severe clinical abnormalities judged by the diagnostics or physical examination by chief doctor or associate doctors. g) Subjects who is suffering from clinically severe diseases within 30 days before the administration of test drugs. h) Subjects who take medicine, health foods including St. John's wort, foods or drinks containing greapefruit, orange, and apple, and supplements, and cannot stop taking these during this clinical study. i) Subjects who smoke or take nicotine within 30 days before the administration of test drugs, and cannot stop smoking during this clinical study j) Subjects who take foods/drinks containing alcohol or caffeine one day before the date of hospital admission, and cannot stop taking these until the final day of this study. k) Subjects whose results of alcohol breath test or uninary drug screening are positive at the timing of screening. l) Subjects whose results of any tests of serological reaction for HBs antigen, HCV antibody or HIV antigen and antibody are positive m) Subjects who is not suitable for this study judged by chief doctor or associte doctors.

研究者

发起方

P-One Clinic,Keikokai Medical Corp.

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