NCT01234792

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

Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed description

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	6 mg Experimental nicotine gum	A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
DRUG	4 mg Nicotine Gum/	A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
DRUG	2 mg Nicotine Gum	A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2010-11-04
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden