Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01967706
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2013-10-18
Brief Title:
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 22 Menthol THS 22 Menthol
Sponsor:
Philip Morris Products SA
Organization:
Philip Morris Products SA
Study Overview
Official Title:
A Single-center Open-label Randomized Controlled Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 22 Menthol THS 22 Menthol Following Single Use in Smoking Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The primary objective of this clinical study is to evaluate the pharmacokinetic PK profile rate and amount of nicotine absorbed following a single use of the THS 22 Menthol mTHS a candidate Modified Risk Tobacco Product compared to the PK profiles from a single use of a menthol cigarette mCC and from a single use of nicotine replacement therapy gum NRT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZRHM-PK-05-JP | OTHER | Philip Morris Products SA | None |