At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
In Brief
A clinical study evaluating NP-1, NP-2, and 4 other interventions for Smoking and Nicotine. Completed, enrolled 31 participants across 1 site.
Detailed Summary
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).
Study Details
Timeline
Interventions
NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
Velo-NP; 10 mg nicotine;
Zyn-NP; 3 mg nicotine;