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Bioequivalence between oral nicotine replacement products and Nicorette® gum.
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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Nicotine, Nicorette® (Nicotine Gum)
Berzelius Clinical Research Center
Johnson & Johnson Consumer & Personal Products Worldwide
Published on BioPortfolio: 2014-08-27T03:14:05-0400
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette...
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.
Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
Nicotine addiction is the proximate cause of disease and death from cigarette smoking. In 1994, we proposed reducing the nicotine content of cigarettes to non-addicting levels to reduce the risk of yo...
Pregnancy-induced increases in nicotine metabolism may contribute to difficulties in quitting smoking during pregnancy. However, the time-course of changes in nicotine metabolism during early and late...
Tobacco is highly addictive and after the development of dependence it is difficult to quit smoking. Therefore, it is important to understand the factors that play a role in the initiation of smoking....
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.
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.
Chewing gum which contains NICOTINE.
SMOKING vapors produced from ELECTRONIC NICOTINE DELIVERY SYSTEMS.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
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