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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: 4 mg nicotine lozenge Drug: 2 mg nicotine lozenge Drug: 2 mg nicotine prototype Drug: 4 mg nicotine prototype |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Dose Bioequivalence Study of 2mg and 4mg Nicotine Lozenges |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2 mg nicotine prototype
2 mg nicotine prototype
|
Drug: 2 mg nicotine prototype
2 mg
|
|
Active Comparator: 2 mg nicotine lozenge
marketed formulation
|
Drug: 2 mg nicotine lozenge
marketed formulation
|
|
Experimental: 4 mg nicotine prototype
4 mg
|
Drug: 4 mg nicotine prototype
4 mg
|
|
Active Comparator: 4 mg nicotine lozenge
4 mg
|
Drug: 4 mg nicotine lozenge
marketed formulation
Other Name: Nicotine
|
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
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00651352 History of Changes |
| Other Study ID Numbers: | S3010567 |
| Study First Received: | March 31, 2008 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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NRT Bioequivalence Nicotine |
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Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |