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Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

NCT03953183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-14

Study results available
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Summary

The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

Conditions

  • Pharmacokinetics

Interventions

OTHER

P3P-1mg

P3P-1mg (P3P product containing 1mg of nicotine.)

OTHER

P3P-2mg

P3P-2mg (P3P product containing 2mg of nicotine.)

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products SA

  • Vasilyuk V Bogdanovich, MD · LLC Scientific Research Center Eco-Safety

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2019-08-14
Completion
2019-10-25

Countries

  • Russia

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 NCT03953183 on ClinicalTrials.gov