NCT01227720

Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Detailed description

This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Experimental Nicotine Replacement Therapy (NRT) 2 mg	2 mg Single-dose of new NRT product (NSL2L)
DRUG	Experimental Nicotine Replacement Therapy (NRT)	4 mg Single-dose of new NRT product
DRUG	Marketed Nicotine Lozenge	2 mg Single-dose of marketed lozenge
DRUG	Marketed Nicotine Lozenge	4 mg Single-dose of marketed lozenge

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2010-10-25
• Last updated: 2012-07-10

Locations

2 sites across 1 country: Sweden