NCT01084707

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (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 multiple-doses 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 steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 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	Oral Nicotine either self-administered or provided by study personnel within 12 hours
DRUG	Nicotine Lozenge	Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
DRUG	Nicotine gum	Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2010-03-10
• Last updated: 2012-07-13
• Results posted: 2010-10-19

Locations

1 site across 1 country: Sweden