NCT01113424

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Detailed description

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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	Nicotine	Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
DRUG	Nicorette® (Nicotine Gum)	Single-dose of marketed nicotine gum 2 mg or 4 mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2010-04-29
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden