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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: Completed NA study of Vaping and Nicotine Vaping, sponsored by Philip Morris Products S.A..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To measure Cmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.
Conditions Studied
Interventions
- OTHER CA35
- OTHER CM35
- OTHER Cig
Study Locations (1)
North Carolina
- High Point Clinical Trials Center (HPCTC) - High Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2022-08-25 |
| Phase | NA |
What the finished NCT05383508 record still lists
NCT05383508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 759-participant average among 18 other Vaping trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05383508's enrollment target sits among peer trials
36 17th of 18 higher than 2 of 18 other Vaping trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vaping trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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