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NCT05383508 · ClinicalTrials.gov registry record · NA

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

A NA study of Vaping and Nicotine Vaping, sponsored by Philip Morris Products S.A..

Completed
Registry status
NA
Development phase
36
Enrollment target
1
Study location

NCT05383508 is a NA study of Vaping and Nicotine Vaping that has completed, run by Philip Morris Products S.A.. The registered enrollment target is 36 participants, below the 759-participant average among 18 other Vaping trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05383508, a NA study of Vaping and Nicotine Vaping, has completed, sponsored by Philip Morris Products S.A..

COMPLETED
Registry status
NA
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design. This study is exploratory and there is no pre-specified hypothesis to be tested.

Conditions Studied

Vaping Nicotine Vaping Nicotine

Interventions

  • OTHER CA35
  • OTHER CM35
  • OTHER Cig

Study Locations (1)

North Carolina

  • High Point Clinical Trials Center (HPCTC) - High Point

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-04-28
Est. Completion 2022-08-25
Phase NA

Sponsor

Philip Morris Products S.A.

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05383508

The ClinicalTrials.gov registry entry for NCT05383508 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 759-participant average among 18 other Vaping trials with a reported enrollment target (95% lower). The listed sponsor is Philip Morris Products S.A., which has 11 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Vaping appearing as the primary indexed condition, and to 3 interventions - of which CA35 is the first listed.

NCT05383508 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05383508 about?

NCT05383508 is a clinical study titled "Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes". This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, p...

What is the current status of trial NCT05383508?

This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2022-04-28. Estimated completion is 2022-08-25.

What conditions does trial NCT05383508 study?

This clinical trial studies the following conditions: Vaping, Nicotine Vaping, Nicotine.

What interventions are being tested in trial NCT05383508?

The interventions under investigation include: CA35 (OTHER), CM35 (OTHER), Cig (OTHER).

Who is sponsoring clinical trial NCT05383508?

This trial is sponsored by Philip Morris Products S.A., which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05383508 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.