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Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

NCT03369340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-01-31

Study results available
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Summary

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

Conditions

  • Pharmacokinetics

Interventions

OTHER

P3P 1

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

OTHER

P3P 2

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

OTHER

P3P 3

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

OTHER

P3P 4

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

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

  • Milko Radicioni, MD · CROSS Research, Arzo, Ticino, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2018-02-01
Completion
2018-05-02

Countries

  • Switzerland

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 NCT03369340 on ClinicalTrials.gov