NCT01238627

Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - A Study in Healthy Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (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 oral nicotine sublingual tablets, 2 mg and 4 mg.

Detailed description

The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Nicotine Sublingual Tablet Mint (NSTM)	A single dose of an experimental NSTM, with a 36-hour washout between visits
DRUG	Marketed Nicotine Tablet	A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2010-11-10
• Last updated: 2012-07-10

Locations

1 site across 1 country: Sweden