Clinical Studies

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

First posted
Oct 10, 2013
Identifier
NCT01959607
Publication Site URL
Topic
Official Title

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

Brief 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.

Summary

Recruitment: Completed

Study Results: Available

Enrollment: 65

Study Type: Interventional

Other IDs: ZRHR-PK-02-JP

Related Publications

Evaluating Use Patterns of a Closed Electronic Nicotine Delivery System Among Adults in the United States Who Smoke Cigarettes Daily: 8-Week Actual Use Study

Perception and Behavior

Barriers to stop smoking (BASS): Results and insights from four years of empirical research in Germany

Perception and Behavior

Unlocking a decade of tobacco heating system post-market surveillance

Post-Market Studies and Surveillance Study

Reasons for oral nicotine product use among adults who smoke or use smoke-free products in Germany - Results from the Barrier to Stopping smoking (BASS) survey

Perception and Behavior

Misunderstanding nicotine delivery: Discussion on nicotine pouches

Nicotine

AeroSolved: Wall Boundary Conditions for Liquid Multispecies Aerosol Deposition at Transient and High-Humidity Flows

Aerosol Physics

PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
​
Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.