At a glance
ClinicalIndex Comparison RecordN/ACompleted· 62 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 Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.
In Brief
A clinical study evaluating THS 2.2, CC, and 1 other intervention for Smoking. Completed, enrolled 62 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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartNov 2013
Primary CompletionDec 2013
Study CompletionJul 2014
TodayJul 2026
First PostedOct 23, 2013
Enrollment StartNov 1, 2013
Primary CompletionDec 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 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 conventional cigarette (CC)
NNSother
Single administration of 1 mg of nicotine