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Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

2014-08-27 03:12:36 | BioPortfolio

Summary

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

Description

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Tobacco Dependence

Intervention

Nicotine

Location

McNeil AB Clinical Pharmacology R&D
Lund
Sweden
SE-222 20

Status

Completed

Source

Johnson & Johnson Consumer & Personal Products Worldwide

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:36-0400

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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.

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The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.

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