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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00651352 |
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 |
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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) |
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.
United States, Nebraska | |
GSK Clinical Trials Call Center | |
Lincoln, Nebraska, United States, 68502 |
Principal Investigator: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
Nicotine Bioequivalence NRT |
Nicotine polacrilex Neurotransmitter Agents Nicotine Nicotinic Agonists |
Central Nervous System Stimulants Peripheral Nervous System Agents Healthy Cholinergic Agents |
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 |