Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01321931
First received: March 22, 2011
Last updated: July 6, 2012
Last verified: July 2012

March 22, 2011
July 6, 2012
February 2011
May 2011   (final data collection date for primary outcome measure)
  • Maximum Observed Plasma Concentration [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
  • Average Concentration [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Average Nicotine Plasma Concentration (Cav) within the last dosing interval
  • Area Under the Curve [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
Same as current
Complete list of historical versions of study NCT01321931 on ClinicalTrials.gov Archive Site
  • Time of Maximum Concentration [ Time Frame: During 12 hours post-dose ] [ Designated as safety issue: No ]
    The time at which maximum concentration is reached (Tmax)
  • Minimum Observed Concentration [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
  • Peak-Trough Fluctuation [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)
  • Swing [ Time Frame: within the last dosing interval (starting at 10.5-11 hours after first product administration) ] [ Designated as safety issue: No ]
    Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin
  • Nicotine Released [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The amount of nicotine released from the product during product administration
Same as current
Not Provided
Not Provided
 
Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Tobacco Dependence
  • Drug: Nicotine
    6 mg experimental Nicotine Replacement Therapy (NRT)
    Other Name: Not yet marketed
  • Drug: Nicotine
    4 mg marketed Nicotine Fruit Gum (NFG)
    Other Name: Nicorette® Freshfruit Gum
  • Drug: Nicotine
    4 mg marketed nicotine mint lozenge (NIQ)
    Other Name: NiQuitinTM Mint lozenge
  • Experimental: NRT 60
    A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits
    Intervention: Drug: Nicotine
  • Active Comparator: NFG 60
    A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits
    Intervention: Drug: Nicotine
  • Experimental: NRT 90
    A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
    Intervention: Drug: Nicotine
  • Active Comparator: NFG 90
    A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
    Intervention: Drug: Nicotine
  • Active Comparator: NIQ 60
    A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits
    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
50
June 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
  • BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
  • 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.
  • Willing and able to comply with all scheduled visits and study procedures

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.
  • Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
Both
19 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01321931
NICTDP1081, 2010-023026-20
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