Unique ID issued by UMIN | UMIN000003637 |
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Receipt number | R000004392 |
Scientific Title | Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people) |
Date of disclosure of the study information | 2010/05/19 |
Last modified on | 2012/07/13 14:19:06 |
Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)
Pharmacokinetic study of acetaminophen
Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)
Pharmacokinetic study of acetaminophen
Japan |
healthy male subjects
Not applicable |
Others
YES
to examine the differences in pharmacokinetics of acetaminophen
Safety
pharmacokinetics of acetaminophen
safety
genetic analysis
Interventional
Parallel
Non-randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
administration of acetaminophen
administration of acetaminophen
20 | years-old | <= |
40 | years-old | > |
Male
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.
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.
16
1st name | |
Middle name | |
Last name | Yuji Kumagai |
Kitasato University East Hospital
Clinical trial Center
2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
1st name | |
Middle name | |
Last name |
Kitasato University East Hospital
Clinical trial Center
2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
Clinical trial Center,Kitasato University East Hospital
Clinical trial Center,Kitasato University East Hospital
Other
NO
2010 | Year | 05 | Month | 19 | Day |
Partially published
Completed
2010 | Year | 04 | Month | 30 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 05 | Month | 19 | Day |
2012 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004392
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