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COMPLETED NA

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

NCT05383508 · View on ClinicalTrials.gov ↗

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.

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.

3 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philip Morris Products S.A., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05383508 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05383508?

The interventions under investigation include: CA35 (OTHER), CM35 (OTHER), Cig (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05383508?

This trial is sponsored by Philip Morris Products S.A., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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