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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)

NCT06171490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-08-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-01-14
Completion
2024-03-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171490 on ClinicalTrials.gov