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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017297
Receipt No. R000020059
Scientific Title A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers
Date of disclosure of the study information 2016/11/21
Last modified on 2016/11/21

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Basic information
Public title A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers
Acronym A pharmacokinetics study for B-001
Scientific Title A pharmacokinetics study of nicotine for B-001 in healthy adult male smokers
Scientific Title:Acronym A pharmacokinetics study for B-001
Region
Japan

Condition
Condition Smokers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the nicotine pharmacokinetics following the use of B-001 in comparison with a popular commercial tobacco product
Basic objectives2 Others
Basic objectives -Others To investigate the nicotine pharmacokinetics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nicotine pharmacokinetic parameters (Cmax, Tmax and AUClast)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Period1:Use of B-001 - Period2:Use of CC1
Interventions/Control_2 Period1:Use of CC1 - Period2:Use of B-001
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
21 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria - Subjects who sign the study-specific consent form
- Subjests who are confirmed to be in good health through the screening process
- Smokers

etc.
Key exclusion criteria - Subjects who have used smoking cessation medications within 4 weeks of the screening, or plan to use the medication until the end of the study
- Subjects whose blood was collected more than 200 ml within 4 weeks prior to the screening, or more than 400 ml within 12weeks prior to the screening (including blood donation)

etc.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Futamura
Organization JAPAN TOBACCO INC.
Division name Scientific Product Assessment Center, Tobacco Business Headquarters
Zip code
Address 6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL 045-973-5611
Email yasuyuki.futamura@jt.com

Public contact
Name of contact person
1st name
Middle name
Last name Aki Nonaka
Organization JAPAN TOBACCO INC.
Division name Scientific Product Assessment Center, Tobacco Business Headquarters
Zip code
Address 6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL 045-973-5611
Homepage URL
Email aki.nonaka@jt.com

Sponsor
Institute JAPAN TOBACCO INC.
Institute
Department

Funding Source
Organization JAPAN TOBACCO INC.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 11 Day
Last follow-up date
2015 Year 05 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 27 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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