Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:41 PM
Study NCT ID:
NCT06093659
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products
Sponsor:
Imperial Brands PLC
Organization:
Study Overview
Official Title:
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco and Heated Herbal Products Compared With Combustible Cigarettes
Status:
COMPLETED
Status Verified Date:
2025-01
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 is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (CCs). The study investigates combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), with endpoints including pharmacokinetic evaluation, and subjective effects.
Subjects will perform a Screening Visit and one Study Visit, including a 6-day confinement period.
Subjects will perform a Screening Visit and one Study Visit, including a 6-day confinement period.
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?: