At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65 enrolled
Drug / intervention
THS 2.2 +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.
A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum
In Brief
A clinical study evaluating THS 2.2, CC, and 1 other intervention for Smoking. Completed, enrolled 65 participants across 1 site.
Detailed Summary
The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedOct 2013
Primary CompletionNov 2013
Study CompletionApr 2014
TodayJul 2026
First PostedOct 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.7 years ago
Interventions
THS 2.2other
Single use of the Tobacco Heating System 2.2 (THS 2.2)
CCother
Single use of subject's own cigarette (CC)
NRT Gumother
Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)