Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
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|ClinicalTrials.gov Identifier: NCT01967706|
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 2, 2016
Last Update Posted : September 5, 2017
|Study Design||Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other|
Study initiated (first subject screened): 01 August 2013
At admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum).
From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences.
Enrolled population = 73 subjects: 11 exposed to mTHS and NRT at Admission but not randomized and 62 randomized as described below: