At a glance
ClinicalIndex Comparison RecordN/ACompleted· 56 enrolled
Drug / intervention
CHTP 1.1 M +1 moreother
Likely dose
Not stated in 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 Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes
In Brief
A clinical study evaluating CHTP 1.1 M and mCC for Smoking. Completed, enrolled 56 participants across 1 site.
Detailed Summary
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedJun 2015
Primary CompletionAug 2015
Study CompletionNov 2015
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartMay 1, 2015
Primary CompletionAug 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.1 years ago
Interventions
CHTP 1.1 Mother
Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
mCCother
Single use of subject's own menthol conventional cigarette (mCC)