NCT01152749

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Detailed description

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	Single-dose of new NRT product
DRUG	Nicotine Gum	Single-dose of marketed nicotine gum

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2010-06-29
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden