Healthy adult male subjects
Conditions
Interventions
Single administration of 7.5 mg tablet of meloxicam
Sponsors
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
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Those who are capable of providing written informed consent. 2) Men aged 20 to 35 years at the time of signing informed consent. 3) BMI of 18.5 to <30.0 and body weight of 50.0 to 100.0 kg at screening. 4) Those who are determined by the investigator to be healthy in the screening test and eligible for the study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of meloxicam | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactShinichi Kawai
Toho University School of Medicine Division of Rheumatology, Department of Internal Medicine
Outcome results
None listed