NCT01238640

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Detailed description

The trial has a single-dose, randomized, crossover design and includes 84 subjects. 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. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Code STD	2 mg Single-dose of experimental nicotine product coded "STD"
DRUG	Code STE	2 mg Single-dose of experimental nicotine product coded "STE"
DRUG	Nicorette Microtab	A comparative 2 mg Single-dose of marketed tablet

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2010-11-10
• Last updated: 2012-07-13
• Results posted: 2011-04-08

Locations

1 site across 1 country: Sweden