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Single-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 single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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

Oral Nicotine, NiQuitinTM Nicotine Lozenge, Nicorette® 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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The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers.

Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges

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Randomized Trial to Compare Smoking Cessation Rates of Snus, with and without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge.

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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.

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

The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.

An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation.

A condition of abnormally low AMNIOTIC FLUID volume. Principal causes include malformations of fetal URINARY TRACT; FETAL GROWTH RETARDATION; GESTATIONAL HYPERTENSION; nicotine poisoning; and PROLONGED PREGNANCY.

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