NCT01321931

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Detailed description

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	6 mg experimental Nicotine Replacement Therapy (NRT)
DRUG	Nicotine	4 mg marketed Nicotine Fruit Gum (NFG)
DRUG	Nicotine	4 mg marketed nicotine mint lozenge (NIQ)

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2011-03-24
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden