NCT06171490

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)

A Multi-center, Randomized, Controlled, Partially Blinded Study to Assess the Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of Nicotine Pouch 2.0 (NP2), 4mg and 6mg, Compared to Nicotine Lozenge 4mg and Nicotine Gum 4mg in Adult Cigarette Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	NP2-4mg	NP2-4 mg is a new product containing tobacco-derived nicotine.
OTHER	NP2-6 mg	NP2-6 mg is a new product containing tobacco-derived nicotine.
OTHER	Loz-4mg	The Loz-4mg reference product is a commercially available 4mg nicotine lozenge.
OTHER	Gum-4mg	The Gum-4mg reference product is a commercially available 4mg nicotine gum.

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-01-14
• Completion: 2024-03-20
• First posted: 2023-12-14
• Last updated: 2024-08-13

Locations

2 sites across 1 country: Canada