NCT01967732

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 Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).

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 conventional cigarette (CC)
OTHER	NNS	Single administration of 1 mg of nicotine

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2013-10-23
• Last updated: 2020-03-17
• Results posted: 2016-08-15

Locations

1 site across 1 country: United Kingdom