Unique ID issued by UMIN | UMIN000003920 |
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Receipt number | R000004712 |
Scientific Title | Clinical research of glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan cocktail-microdose to validate the utility of microdose study on the Cytochrome P450 SNP's |
Date of disclosure of the study information | 2010/08/01 |
Last modified on | 2011/01/20 14:50:19 |
Clinical research of glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan cocktail-microdose to validate the utility of microdose study on the Cytochrome P450 SNP's
CYP probe cocktail-microdose
Clinical research of glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan cocktail-microdose to validate the utility of microdose study on the Cytochrome P450 SNP's
CYP probe cocktail-microdose
Japan |
healthy male
Not applicable |
Others
YES
To evaluate PK profiles of cocktail-dose of glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan, and to assess the effect of dosage form, then to identify the relationship between PK profiles and regarded genes.
Pharmacokinetics
PK profiles of glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
glibenclamide, warfarin, metoprolol, lansoprazole and dextromethorphan
20 | years-old | <= |
45 | years-old | >= |
Male
the investigors must ensure that all subjects being considerd meet the following inclusion
criteria: 1) Japanese healthy male who is capable to understand and sign the informed consent. 2) 20-45 years of age 3)BMI 18.5-25.0 4)good health as determined by physical examination, vital signs and laboartory tests.
the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions: 1)history of allergy to any drugs 2)medical attention within 2 months prior to participation 3)donation of 200mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4)donation of 400mL or more of blood within 12 weeks prior to participation 5)recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6)history of drug abuse 7)alcohol abuse 8)lactose intolerance
20
1st name | |
Middle name | |
Last name | Shin Irie |
ETA
Kyushu Clinical Pharmacology Clinic
2-13-16 Jigyo Fukuoka
1st name | |
Middle name | |
Last name | Miyuki Kimura |
ETA
Kyushu Clinical Pharmacology Clinic
092-733-1001
APDD
APDD
NO
2010 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2010 | Year | 06 | Month | 21 | Day |
2010 | Year | 07 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2010 | Year | 07 | Month | 16 | Day |
2011 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004712
Research Plan | |
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Research case data | |
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