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Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

Tobacco Dependence Clinical Trial

Official title:
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Clinical Trial Summary

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

Clinical Trial Description

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01152736
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date January 2009
View Details
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