NCT01967706

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 Gum.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 23 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	mTHS	Single use of Tobacco Heating System 2.2 Menthol (mTHS)
OTHER	mCC	Single use of subject's own menthol cigarette (mCC)
OTHER	NRT	Single administration of 2 mg gum (Nicorette® 2mg)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2013-10-23
• Last updated: 2020-03-18
• Results posted: 2016-02-02

Locations

1 site across 1 country: Japan