NCT01084603

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Detailed description

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Oral Nicotine	A new l mg oral nicotine product
DRUG	NiQuitinTM Nicotine Lozenge	A marketed 4 mg Nicotine lozenge
DRUG	Nicorette® Nicotine Gum	A marketed 4 mg Nicotine Gum

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2010-03-10
• Last updated: 2012-07-13
• Results posted: 2010-07-08

Locations

1 site across 1 country: Sweden