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

June 28, 2010
July 6, 2012
November 2008
December 2008   (final data collection date for primary outcome measure)
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∞)
Same as current
Complete list of historical versions of study NCT01152736 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Dependence
Drug: Nicotine
2 mg Single-dose
Other Name: Experimental NRT, Nicorette®
  • Experimental: NSC018
    Nicotine
    Intervention: Drug: Nicotine
  • Active Comparator: Nicotine Gum
    Nicorette® Gum
    Intervention: Drug: Nicotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
January 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01152736
NICTDP1073, 2008-005520-87
No
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
McNeil AB
Not Provided
Study Director: Elisabeth Kruse, PhD McNeil AB
Johnson & Johnson Consumer and Personal Products Worldwide
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP