Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04429932
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2020-06-10
Brief Title:
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes
Sponsor:
Fontem US LLC
Organization:
Fontem Ventures BV
Study Overview
Official Title:
An Open-Label Randomized Crossover Study to Assess Nicotine Uptake Tobacco-Related Biomarkers of Exposure Biomarkers of Potential Harm and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods as assessed by nicotine uptake exposure to smoke constituents safety and consumer satisfaction over 8 days The study is designed as an open-label randomized study in adult smokers
Subjects are invited to participate to a second part of the study for 5 additional days to compare the use of MybluTM to the use of subjects usual brand combustible cigarettes
Subjects are invited to participate to a second part of the study for 5 additional days to compare the use of MybluTM to the use of subjects usual brand combustible cigarettes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None