Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)
- Conditions
- healthy male subjects
- Registration Number
- JPRN-UMIN000003637
- Lead Sponsor
- Clinical trial Center,Kitasato University East Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 16
Not provided
1)Any subject with a past history of anaphylaxis due to acetaminophen. 2)Any subject with peptic ulcer. 3)Any subject with blood abnormality,hepatopathy, kidney damage or cardiac dysfunction. 4)Aspirin-induced asthma or a history of diseases of aspirin-induced asthma. 5)Alcohol drinkers (daily alcohol intake of 30 g or more in the past 3 months). 6)Use of a health food product containing Saint John's wort or use of a drug within 14 days before study drug administration. 7)Intake of any beverage or drink containing grapefruit, orange, or apple juice within 7 days of beginning study drug administration. 8)Participation in any other clinical trial within the past 3 months. 9)Persons who have donated more than 200 ml of blood in the past 1 month or more than 400 ml of blood in the past 3 months. 10)Anyone with a positive serological response for syphilis, HIV antigen or antibody, HBs antigen, or HCV antibody. 12)Anyone known to abuse drugs or who tests positive for a drug in urine screening tests. 13)Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics of acetaminophen
- Secondary Outcome Measures
Name Time Method safety genetic analysis