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
- Conditions
- Healthy adult male subjects
- Registration Number
- JPRN-UMIN000004173
- Lead Sponsor
- 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
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 120
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of meloxicam
- Secondary Outcome Measures
Name Time Method Safety