JPRN-UMIN000003644已完成未知
Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Joint Statement by the Japanese, Chinese and Korean Ministers of Health: Clinical Pharmacokinetic Study of Simvastatin in Healthy Adult Male Subjects. - Comparative Pharmacokinetic Study of Simvastatin among Japan, Korea, China, and USA.
Research Group of Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Announcement by the Japanese, Chinese and Korean Ministers of Health, Labor and Welfare0 个研究点目标入组 160 人开始时间: 2010年6月1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
- 160
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 35years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1)Organopathy involving the heart, lung, liver and/or kidney, etc. 2)A history of diseases involving the heart, lung, kidney, blood (such as coagulation system disorder), central nervous system and metabolic system that may interfere with the study. 3)Hypothyroidism, genetic myopathy or family history of it, history of drug-induced myopathy 4)Hypersensitivity or allergies to drugs, food, etc. (Particularly, a history of allergy to or adverse reactions associated with statin-type antihyperlipidemia drugs) 5)Oral administration of drugs such as over-the-counter drugs, health foods (supplements) that may affect metabolism of the test drug, grapefruit and drink/food including grapefruit within 1 week prior to the study drug administration, or taking drink including caffeine or green tea within 3 days prior to the study drug administration, or the necessity for using other medications before study completion. 6)Smokers or a smoking history within the last 6 months. (The cotinine test is performed, if necessary) 7)Drug abuse or suspicion of drug abuse. (The drug screening test is performed, if necessary) 8)Alcohol drinkers (daily alcohol intake of 50 g or more). 9)Total bilirubin or direct bilirubin is 1.5 times higher, AST, ALT and ALP is 2.5 times higher, or other liver and renal function tests items are 1.25 times higher than the upper limits of normal at the sites. The creatinine clearance (calculated by Cockcroft-Gault formula) is lower than the normal range at the sites. 10)Transfusion of 200 mL or more within 1 month prior to study drug administration, blood component donation (plasma or platelet) within 2 weeks, or blood collection of 400 mL or more within 3 months. 11)Those who are determined by the investigator to be not suitable as subjects of the study.
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