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Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

2014-08-27 03:14:05 | BioPortfolio

Summary

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Description

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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

Nicotine, Nicorette® (Nicotine Gum)

Location

Berzelius Clinical Research Center
Linköping
Sweden
SE-582 25

Status

Completed

Source

Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:05-0400

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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.

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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Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

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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