Tobacco Product Users and Never smokers
Conditions
Interventions
None listed
Sponsors
JAPAN TOBACCO INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who sign the study-specific consent form - Ploom X user: Subjects who use Ploom X exclusively more than three months - Cigarette smoker: Subjects who smoke cigarettes exclusively more than one year - Never smoker: Subjects who have never used tobacco products and nicotine containing products etc.
Exclusion criteria
Exclusion criteria: - Subjects who have, or who have a history of, any clinically significant cardiovascular, hepatic, renal, hematological, respiratory, endocrine, metabolic, electrolyte imbalance - Subjects who have received any investigational drug within 4 months prior to the study period - Pregnant or lactating women or women who may be pregnant - Subjects who have positive test result of SARS-CoV-2 test at screening - Subjects who are employed in the tobacco industries, CRO or clinical facility etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of biomarker of exposure and biomarkers of potential harm in Ploom X users relative to cigarette smokers and never smokers | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference of the level of cough in Ploom X users relative to cigarette smokers and never smokers | — |
Countries
Japan
Contacts
Public ContactChikako Sakaguchi
JAPAN TOBACCO INC. Scientific and Regulatory Affairs, Tobacco Business
Outcome results
None listed