healthy male subjects
Conditions
Interventions
administration of acetaminophen
administration of acetaminophen
Sponsors
Clinical trial Center,Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Those who have ability to provide written consent to participate in the study. 2)Healthy male subjects between the ages of 20 and 40 years at the time of obtaining informed consent. 3)Body weight between 50 kg and 100 kg, and a body mass index(BMI)between 18.5 and 27 kg/m2. 4)Judged to be healthy by the study physician based on medical examinations and clinical laboratory tests.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics of acetaminophen | — |
Secondary
| Measure | Time frame |
|---|---|
| safety genetic analysis | — |
Countries
Japan
Outcome results
None listed