At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
In Brief
A clinical study evaluating Product A, Product B, and 2 other interventions for Healthy Volunteers. Completed, enrolled 27 participants across 1 site.
Detailed Summary
This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation. During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.
Study Details
Timeline
Interventions
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes