Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171490
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-12-06
Brief Title:
Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2 NP2-4mg and NP2-6mg Compared to Nicotine Lozenge 4mg Loz-4mg and Nicotine Gum 4mg Gum-4mg
Sponsor:
Philip Morris Products SA
Organization:
Philip Morris Products SA
Study Overview
Official Title:
A Multi-center Randomized Controlled Partially Blinded Study to Assess the Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of Nicotine Pouch 20 NP2 4mg and 6mg Compared to Nicotine Lozenge 4mg and Nicotine Gum 4mg in Adult Cigarette Smokers
Status:
COMPLETED
Status Verified Date:
2024-08
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 multi-center randomized controlled partially blinded study to assess the pharmacokinetics and comparative bioavailability of nicotine from two variants of NP2 4 and 6 mg in comparison with Loz-4mg and Gum-4mg in adult cigarette smokers The subjects will be blinded to the randomized sequence and will be blinded to the variants of NP2 they will receive The study will be conducted with 4 periods and 4 sequences in a Williams design crossover
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