A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00651352
First received: March 31, 2008
Last updated: June 19, 2014
Last verified: February 2014
  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 1

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

Resource links provided by NLM:


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. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

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; [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • • To evaluate the safety of the 2mg and 4mg prototype lozenges. [ Time Frame: Study period ] [ Designated as safety issue: No ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651352

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00651352     History of Changes
Other Study ID Numbers: S3010567
Study First Received: March 31, 2008
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
NRT
Bioequivalence
Nicotine

Additional relevant MeSH terms:
Nicotine
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

ClinicalTrials.gov processed this record on October 19, 2014