CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
mTHS +2 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.

Search/NCT01967706
NCT01967706N/ACompleted
CompareCT.gov

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.

Philip Morris Products S.A.·interventional·Posted Oct 23, 2013·Updated Mar 18, 2020

In Brief

A clinical study evaluating mTHS, mCC, and 1 other intervention for Smoking. Completed, enrolled 73 participants across 1 site.

Detailed Summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 23, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.7 years ago

Interventions

mTHSother

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

mCCother

Single use of subject's own menthol cigarette (mCC)

NRTother

Single administration of 2 mg gum (Nicorette® 2mg)