At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
P3P-1mg +1 moreother
Likely dose
P3P-1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month
In Brief
A clinical study evaluating P3P-1mg and P3P-2mg for Pharmacokinetics. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesRussia
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionAug 2019
Study CompletionOct 2019
TodayJul 2026
First PostedMay 16, 2019
Enrollment StartApr 23, 2019
Primary CompletionAug 14, 2019
Study CompletionOct 25, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.1 years ago
Interventions
P3P-1mgother
P3P-1mg (P3P product containing 1mg of nicotine.)
P3P-2mgother
P3P-2mg (P3P product containing 2mg of nicotine.)