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

2014-08-27 03:15:18 | BioPortfolio

Summary

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

Description

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tobacco Dependence

Intervention

Experimental Nicotine, Nicotine Lozenge, Nicotine gum

Location

Clinical Pharmacology
Lund
Sweden
222 20

Status

Completed

Source

Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:18-0400

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Medical and Biotech [MESH] Definitions

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Chewing gum which contains NICOTINE.

SMOKING vapors produced from ELECTRONIC NICOTINE DELIVERY SYSTEMS.

SMOKING of non-TOBACCO (or NICOTINE-containing) substances.

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

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