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A Single Dose Bioequivalence Study Of Two Formulations Of Nicotine Lozenges
This study has been completed.
First Received: March 31, 2008   Last Updated: April 14, 2008   History of Changes
Sponsored by: 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

Drug Information available for: Nicotine tartrate Nicotine polacrilex
U.S. FDA Resources
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge.

Secondary Outcome Measures:
  • • To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise with the 4mg prototype lozenge to 4mg standard lozenge;
  • • To evaluate the safety of the 2mg and 4mg prototype 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
Criteria

Inclusion Criteria:

  • Subject is either male or female between 18 - 55 years of age inclusive.
  • Subject has a BMI within the range 19-27 kg/m². [BMI = Weight (kg) ÷ Height (m)²].
  • Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinely smoking his or her first cigarette within 30 minutes upon awakening.
  • Subject is in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities as assessed by medical history, physical examination, electrocardiogram (ECG) and clinical laboratory test results (hematology, biochemistry and urinalysis) are within normal limits.
  • If female, subject of childbearing potential is practicing a reliable method of contraception in the opinion of the investigator.
  • Subject understands and is willing, able, and likely to comply with all study procedures and restrictions.
  • Subject demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

  • If female, subject is pregnant, has a positive serum pregnancy test during screening, or is breast-feeding.
  • Subject has a disease or condition that may interfere with the oral absorption of the study drugs.

    1. A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject (e.g. rheumatoid arthritis, circulatory problems, recent myocardial infarction, cerebrovascular accident within 12 weeks prior to first study session, unstable or worsening angina pectoris, Prinzmetal's angina or severe cardiac arrhythmia).
    2. A medical history which, in the opinion of the investigator, might impact the validity of the study results and may require pharmacotherapy or prevent the subject from finishing the study.
    3. Oral surgery within 4 weeks of dosing, dental work or extractions within 2 weeks of dosing, or presence of any clinically significant (as determined by the principal investigator) oral pathology including lesions, sores or inflammation.
  • Subject has used chewing tobacco or tobacco products other than cigarettes within 21 days of Visit 1.
  • Subject has abused alcohol or other substances within two years of screening. For the purposes of this study, alcohol abuse is defined as daily use of greater than two drinks per day.
  • Subject has a positive urine drug screen for cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine, or opiates.
  • Subject has a positive serum hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) test result.
  • Subject has known or suspected intolerance or hypersensitivity to any of the study materials or closely related compounds or any of their stated ingredients.
  • Subject has a genetic deficiency with an inability to metabolize aspartame or phenylalanine, or has been diagnosed with phenylketonuria.
  • Subject has participated in another clinical study or received an investigational drug within 30 days of the first study session or previously participated in this study.
  • Subject has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2, or has a hemoglobin value of <12.0g/dL.
  • Subject has been treated with any known enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, theophyllines) within 30 days prior to the first study session.
  • Subject has used any nicotine replacement therapy within 21 days prior to the first study session.
  • Subject has used any over-the-counter (OTC) medication or herbal supplements within 48 hours prior to administration of study treatment.
  • Subject has used any prescription medication within 14 days prior to each study session, excluding hormonal contraceptive or hormone replacement therapy.
  • Subject is a member of the study site staff or an employee of the sponsor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651352

Locations
United States, Nebraska
GSK Clinical Trials Call Center
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Principal Investigator: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:
Nicotine
Bioequivalence
NRT

Study placed in the following topic categories:
Nicotine polacrilex
Neurotransmitter Agents
Nicotine
Nicotinic Agonists
Central Nervous System Stimulants
Peripheral Nervous System Agents
Healthy
Cholinergic Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009