Unique ID issued by UMIN | UMIN000006215 |
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Receipt number | R000007353 |
Scientific Title | A study of the changes of biomarkers for various types of tobacco in healthy adult male smokers |
Date of disclosure of the study information | 2012/12/31 |
Last modified on | 2014/01/07 10:45:11 |
A study of the changes of biomarkers for various types of tobacco in healthy adult male smokers
A biomarker study for various types of tobacco
A study of the changes of biomarkers for various types of tobacco in healthy adult male smokers
A biomarker study for various types of tobacco
Japan |
Smokers, nonsmokers
Adult |
Others
NO
To investigate the change of biomarkers by various types of tobacco for smokers staying at designated sites
Others
For nonsmokers to investigate the non tobacco-specific effects on biomarkers on site and at home and for smokers to investigate the change and the variability of biomarkers by various types of tobacco at home
To investigate the change of biomarkers in healthy adult male smokers on site during four-week use of various types of tobacco in comparison with a conventional tobacco product
Interventional
Parallel
Randomized
Open -no one is blinded
No treatment
4
Prevention
Food |
<Smokers> Smoking of subject's usual cigarette brand (on site, for 2 days) => Smoking of A-705 (on site, for 28 days) => Smoking of A-705 (at home, for 28 days)
<Smokers> Smoking of subject's usual cigarette brand (on site, for 2 days) => Use of A-805 (on site, for 28 days)
<Smokers> Smoking of subject's usual cigarette brand (on site, for 2 days) => Smoking of a conventional tobacco product (on site, for 28 days) => Smoking of a conventional tobacco product (at home, for 28 days)
<Nonsmokers> No tobacco product use
21 | years-old | <= |
50 | 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. For smokers, subjects who do not plan to quit smoking over the study period
4. For nonsmokers, subjects who do not plan to use tobacco products over the study period
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) or subjects who donate plasma or platelet within 4 weeks before screening
etc.
120
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
2012 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2011 | Year | 08 | Month | 02 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 23 | Day |
2014 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007353
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