Bioequivalence Between Nicotine Replacement Products 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:
NCT01113424
First received: April 28, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

Bioequivalence between oral nicotine replacement products and Nicorette® gum.


Condition Intervention
Tobacco Dependence
Drug: Nicotine
Drug: Nicorette® (Nicotine Gum)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Between Oral Nicotine Replacement Products 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 (AUCinf)


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

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

  • Residual Nicotine [ Time Frame: After 30 minutes of chewing ] [ Designated as safety issue: No ]
    The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.

  • Dissolution Time [ Time Frame: From product administration until completely dissolved ] [ Designated as safety issue: No ]
    Actual time required for oral dissolution of new NRT products following product administration


Enrollment: 88
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NRT-2
2 mg single-dose of a new NRT product
Drug: Nicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
Other Name: Not yet marketed
Active Comparator: GUM-2
2 mg single-dose of a marketed nicotine gum
Drug: Nicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg
Other Name: Nicorette®
Experimental: NRT-4
4 mg single-dose of a new NRT product
Drug: Nicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
Other Name: Not yet marketed
Active Comparator: GUM-4
4 mg single-dose of marketed nicotine gum
Drug: Nicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg
Other Name: Nicorette®

Detailed Description:

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy smokers, 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: NCT01113424

Locations
Sweden
Berzelius Clinical Research Center
Linköping, Sweden, SE-582 25
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: NCT01113424     History of Changes
Other Study ID Numbers: NICTDP1071, 2008-003358-14
Study First Received: April 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 17, 2014