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

Tobacco Dependence Clinical Trial

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

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Dependence

• NCT number: NCT01238627
• Study type: Interventional
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Completion date: November 2007