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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00651352 |
Purpose
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer Smokers |
Drug: Nicotine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
| Official Title: | A Single Dose Bioequivalence Study of 2mg and 4mg Nicotine Lozenges |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2008 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subject has a disease or condition that may interfere with the oral absorption of the study drugs.
Contacts and Locations| United States, Nebraska | |
| GSK Clinical Trials Call Center | |
| Lincoln, Nebraska, United States, 68502 | |
| Principal Investigator: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | S3010567 |
| Study First Received: | March 31, 2008 |
| Last Updated: | April 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651352 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Nicotine Bioequivalence NRT |
|
Nicotine polacrilex Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |