Unique ID issued by UMIN | UMIN000002472 |
---|---|
Receipt number | R000003031 |
Scientific Title | A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers |
Date of disclosure of the study information | 2010/07/31 |
Last modified on | 2010/07/30 17:48:17 |
A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers
A pharmacokinetics study for A-801
A pharmacokinetics study of nicotine for A-801 in healthy adult male smokers
A pharmacokinetics study for A-801
Japan |
Smokers
Not applicable |
Others
NO
To investigate the nicotine pharmacokinetics including exposure level during the use of A-801 in comparison with a popular commercial tobacco product
Others
To investigate the nicotine pharmacokinetics
To investigate the nicotine pharmacokinetics including exposure level during the use of A-801 in comparison with a popular commercial tobacco product
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Washout period
=> Step1: Use of A-801
=> Washout period
=> Step2: Use of a popular commercial tobacco product
21 | years-old | <= |
40 | years-old | > |
Male
1. Subjects who sign the study-specific consent form
2. Subjects who are confirmed to be in good health through the screening process
3. Smokers
4. Subjects who do not plan to quit smoking over the study period (from screening to step 2)
etc.
1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco
2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation)
etc.
12
1st name | |
Middle name | |
Last name | Tsuyoshi Moriyama |
JAPAN TOBACCO INC.
Product Science Division, R&D Group, Tobacco Business Headquarters
1-17-7, Yokokawa, Sumida-ku, Tokyo
1st name | |
Middle name | |
Last name |
JAPAN TOBACCO INC.
Product Science Division, R&D Group, Tobacco Business Headquarters
1-17-7, Yokokawa, Sumida-ku, Tokyo
JAPAN TOBACCO INC.
None
Self funding
NO
2010 | Year | 07 | Month | 31 | Day |
Unpublished
Completed
2009 | Year | 08 | Month | 31 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 09 | Month | 09 | Day |
2010 | Year | 07 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003031
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