Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

McNeil AB40 enrolled

Overview

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tobacco Dependence

Interventions

Oral NicotineDRUG

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Nicotine LozengeDRUG

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

Nicotine gumDRUG

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2. * Female participants of child-bearing potential are required to use a medically acceptable means of birth control. * A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. Exclusion Criteria: * Pregnancy, lactation or intended pregnancy. * Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication. * Prior regular use of nicotine mouth spray

Locations (1)

Clinical Pharmacology

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Plasma Concentration

Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)