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Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227720
First Posted: October 25, 2010
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
  Purpose
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Condition Intervention
Tobacco Dependence Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg Drug: Experimental Nicotine Replacement Therapy (NRT) Drug: Marketed Nicotine Lozenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):

Primary Outcome Measures:
  • Maximum Plasma Concentration [ Time Frame: during 12 hours after product administration ]
    The maximum observed nicotine concentration in plasma (Cmax)

  • Area under the Curve [ Time Frame: after 12 hours ]
    The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)


Secondary Outcome Measures:
  • Time of Maximum Concentration [ Time Frame: during 12 hours after start of product administration ]
    The time of occurrence of maximum concentration (Tmax)

  • Terminal Elimination Rate Constant [ Time Frame: during 12 hours after start of product administration ]
    The terminal nicotine elimination rate constant (λz)

  • Oral Dissolution Time [ Time Frame: from administration until completely dissolved ]
    Actual time required for oral dissolution


Enrollment: 104
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A NSL2L
Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg
Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg
2 mg Single-dose of new NRT product (NSL2L)
Other Name: Not yet marketed
Active Comparator: B Lozenge
Marketed Nicotine Lozenge 2 mg
Drug: Marketed Nicotine Lozenge
2 mg Single-dose of marketed lozenge
Other Name: NiQuitin™ lozenge
Experimental: C NSL4M
Experimental NRT (M) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
4 mg Single-dose of new NRT product
Other Name: Not yet marketed
Active Comparator: D Lozenge
Marketed Nicotine Lozenge 4 mg
Drug: Marketed Nicotine Lozenge
4 mg Single-dose of marketed lozenge
Other Name: NiQuitin™ lozenge
Experimental: E NSL4L
Experimental NRT (L) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
4 mg Single-dose of new NRT product
Other Name: Not yet marketed
Experimental: F NSL4H
Experimental NRT (H) 4 mg
Drug: Experimental Nicotine Replacement Therapy (NRT)
4 mg Single-dose of new NRT product
Other Name: Not yet marketed

Detailed Description:
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227720


Locations
Sweden
Lund University Hospital Clinical Trial Unit
Lund, Sweden, SE-221 85
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

Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT01227720     History of Changes
Other Study ID Numbers: NICTDP1076
First Submitted: October 22, 2010
First Posted: October 25, 2010
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):
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
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action