Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01228617
First received: October 25, 2010
Last updated: October 4, 2011
Last verified: October 2011

October 25, 2010
October 4, 2011
September 2007
October 2007   (final data collection date for primary outcome measure)
  • Maximum Concentration [ Time Frame: Baseline to 10 hours post-dose ] [ Designated as safety issue: No ]
    The maximum observed nicotine concentration in plasma (Cmax)
  • Area under the Curve [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    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∞)
Same as current
Complete list of historical versions of study NCT01228617 on ClinicalTrials.gov Archive Site
  • Time to Maximum Concentration [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    Time to Maximum Concentration (Tmax)
  • Residual Nicotine [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The amount of residual nicotine in the product after being chewed.
  • Dissolution Time [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    Actual time required for oral dissolution of new NRT products following product administration
Same as current
Not Provided
Not Provided
 
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Tobacco Dependence
  • Drug: Nicotine
    Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
    Other Name: Not yet marketed
  • Drug: Nicotine Gum
    Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
    Other Name: Nicorette®
  • Experimental: A1 Short, no buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Experimental: A2 Short, low buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Experimental: A3 Short, high buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Experimental: B1 Long, no buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Experimental: B2 Long, low buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Experimental: B3 Long, high buffer
    Nicotine / not yet marketed
    Intervention: Drug: Nicotine
  • Active Comparator: R = Nicotine Gum
    Nicorette® Gum
    Intervention: Drug: Nicotine Gum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01228617
A6431114-NICTDP1063
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Elisabeth Kruse, PhD McNeil AB
Johnson & Johnson Consumer and Personal Products Worldwide
October 2011

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