NCT01967719

Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

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 Nasal Spray

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	mTHS 2.2	Single use of mTHS 2.2
OTHER	mCC	Single use of subject's own mCC
OTHER	NNS	Single administration of 1 mg of nicotine

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2013-10-23
• Last updated: 2020-03-18
• Results posted: 2017-02-07

Locations

1 site across 1 country: United States