Pharmacokinetics With a New 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:
NCT01152736
First received: June 28, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.


Condition Intervention
Tobacco Dependence
Drug: Nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-dose Nicotine Pharmacokinetics With a New 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 8 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 8 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 8 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: 19
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NSC018
Nicotine
Drug: Nicotine
2 mg Single-dose
Other Name: Experimental NRT, Nicorette®
Active Comparator: Nicotine Gum
Nicorette® Gum
Drug: Nicotine
2 mg Single-dose
Other Name: Experimental NRT, Nicorette®

Detailed Description:

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 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. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

  Eligibility

Ages Eligible for Study:   18 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152736

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: NCT01152736     History of Changes
Other Study ID Numbers: NICTDP1073, 2008-005520-87
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
Mental Disorders
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

ClinicalTrials.gov processed this record on April 14, 2014