Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01152749
First received: June 28, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.


Condition Intervention
Tobacco Dependence
Drug: Nicotine
Drug: Nicotine Gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Pharmacokinetic measurements [ Time Frame: Baseline and during 10 hours after product administration ] [ Designated as safety issue: No ]

    Pharmacokinetic measurements including:

    • the maximum observed nicotine concentration in plasma (Cmax)
    • the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)
    • the area under the plasma concentration-vs.-time curve until infinity (AUC∞)


Secondary Outcome Measures:
  • tmax [ Time Frame: Baseline and during 10 hours after product administration ] [ Designated as safety issue: No ]
    The time of occurrence of Cmax following product administration

  • Lamda z [ Time Frame: Baseline and during 10 hours after product administration ] [ Designated as safety issue: No ]
    The terminal nicotine elimination rate constant (λz)

  • Released amount of nicotine [ Time Frame: After 30 minutes of chewing ] [ Designated as safety issue: No ]
    The amount of nicotine released from gums during 30 minutes' chewing.


Enrollment: 76
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UNG-GC-2
2 mg experimental NRT product
Drug: Nicotine
Single-dose of new NRT product
Other Name: Nicotine NRT / not yet marketed
Experimental: UNG-GC-4
4 mg experimental NRT product
Drug: Nicotine
Single-dose of new NRT product
Other Name: Nicotine NRT / not yet marketed
Active Comparator: Nicorette® Gum-2
2 mg Nicorette® Gum
Drug: Nicotine Gum
Single-dose of marketed nicotine gum
Other Name: Nicorette® Gum
Active Comparator: Nicorette® Gum-4
4 mg Nicorette® Gum
Drug: Nicotine Gum
Single-dose of marketed nicotine gum
Other Name: Nicorette® Gum

Detailed Description:

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (BMI) between 17.5 and 30.0 kg/m2.
  • Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
  • A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Pregnancy, lactation or intended pregnancy.
  • Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
  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: NCT01152749

Locations
Sweden
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01152749     History of Changes
Other Study ID Numbers: NICTDP1075, 2009-010633-44
Study First Received: June 28, 2010
Last Updated: July 6, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation
Nicotine pharmacokinetics

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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 September 14, 2014