NCT01152736

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	2 mg Single-dose

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2010-06-29
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden