NCT01959607

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

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

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

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.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	THS 2.2	Single use of the Tobacco Heating System 2.2 (THS 2.2)
OTHER	CC	Single use of subject's own cigarette (CC)
OTHER	NRT Gum	Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-11-01
• Completion: 2014-04-01
• First posted: 2013-10-10
• Last updated: 2025-01-16
• Results posted: 2015-07-28

Locations

1 site across 1 country: Japan