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Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers

NCT05317195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-09-27

Study results available
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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).

Conditions

  • Smoking
  • Nicotine

Interventions

OTHER

NP-1

NP-1; 8.4 mg nicotine; pH 8.0; moisture 30

OTHER

NP-2

NP-2; 8.4 mg nicotine; pH 9.0; moisture 30

OTHER

NP-3

NP-3; 3.6 mg nicotine; pH 8.0; moisture 15

OTHER

NP-4

NP-4; 3.6 mg nicotine; pH 8.0; moisture 30

OTHER

Velo-NP

Velo-NP; 10 mg nicotine;

OTHER

Zyn-NP

Zyn-NP; 3 mg nicotine;

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Rajkumar Chetty, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2022-05-07
Completion
2022-08-18

Countries

  • United Kingdom

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 NCT05317195 on ClinicalTrials.gov