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临床试验/JPRN-UMIN000004173
JPRN-UMIN000004173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 Meloxicam in Healthy Adult Male Subjects - Comparative Pharmacokinetic Study of Meloxicam 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 120 人开始时间: 2010年10月14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
120

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)Persons with diseases of heart, lung, kidney, blood, central nervous system and metabolic system, peptic ulcer, inflammatory enteropathy, hypertension, asthma and diseases of skeletal muscles, etc. and those with a history of any of the above diseases. 3)Persons with hypersensitivity or allergy to drugs, foods, etc. 5)Persons who are smoking or those have stopped smoking in 6 months. (the cotinine test is conducted if necessary.) 6)Persons who are drug-dependent or those suspected to be drug-dependent. (drug screening is conducted if necessary.) 7)Habitual alcohol drinkers (persons with 50 g or more of alcohol intake per day). 8)Total bilirubin or direct bilirubin, AST, ALT and ALP is 1.5 times higher, or other liver and renal function tests items are 1.25 times higher than the upper limits of normal at the sites. 9)Persons who underwent 200 mL or more of blood collection within one month, blood component donation (plasma or platelet) within two weeks or those who underwent more than 400 mL blood collection within 3 months before administration of the study drug. 10)Persons who participated in a phase I study on drugs containing new active ingredient within 4 months, or those who participated in other studies and received administration within 3 months, before administration of the study drug (For patch test, those who received within one month before administration of the study drug). And persons who participated in any of the above studies and received administration outside the defined period shall also be excluded, if determined to be inappropriate for participation in the study, considering the characteristics of the previous investigational product. 11)Other persons determined by the principal investigator to be inappropriate for the study.

研究者

发起方
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 Welfare

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