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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01084603
First received: March 9, 2010
Last updated: July 6, 2012
Last verified: July 2012

March 9, 2010
July 6, 2012
March 2009
May 2009   (final data collection date for primary outcome measure)
  • Maximum Plasma Concentration [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
    Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
  • Bioavailability [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).
Pharmacokinetic measurements [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
Pharmacokinetic measurements including cCmax, cAUCt and cAUC∞
Complete list of historical versions of study NCT01084603 on ClinicalTrials.gov Archive Site
  • Nicotine Plasma Concentration [ Time Frame: During 10 minutes after start of administration ] [ Designated as safety issue: No ]
    Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
  • Time of Maximum Concentration [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
    The time at which maximum concentration is reached (Tmax)
  • Terminal Elimination Rate Constant [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
    The terminal nicotine elimination rate constant (Lamda z)
  • Released Nicotine [ Time Frame: After 30 minutes' chewing ] [ Designated as safety issue: No ]
    The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
  • AUC 10 minutes [ Time Frame: During 10 minutes after start of administration ] [ Designated as safety issue: No ]
    Area under the nicotine plasma concentration curve (AUC10 min)
  • tmax [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
    The time of occurrence of Cmax (tmax)
  • λz [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]
    The terminal nicotine elimination rate constant (λz)
  • Nicotine Released [ Time Frame: After 30 minutes' chewing ] [ Designated as safety issue: No ]
    The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
Not Provided
Not Provided
 
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Dependence
  • Drug: Oral Nicotine
    A new l mg oral nicotine product
    Other Name: Experimental nicotine 1 mg
  • Drug: NiQuitinTM Nicotine Lozenge
    A marketed 4 mg Nicotine lozenge
    Other Name: NiQuitinTM lozenge
  • Drug: Nicorette® Nicotine Gum
    A marketed 4 mg Nicotine Gum
    Other Name: Nicorette® gum
  • Experimental: Oral Nicotine 1
    One oral administration of 1 mg nicotine
    Intervention: Drug: Oral Nicotine
  • Experimental: Oral Nicotine 2
    Two oral administrations of 1 mg nicotine
    Intervention: Drug: Oral Nicotine
  • Experimental: Oral Nicotine 4
    Four oral administrations of 1 mg nicotine
    Intervention: Drug: Oral Nicotine
  • Active Comparator: NiQuitinTM Nicotine Lozenge 4 mg
    One 4 mg marketed nicotine lozenge
    Intervention: Drug: NiQuitinTM Nicotine Lozenge
  • Active Comparator: Nicorette® Gum 4 mg
    One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
    Intervention: Drug: Nicorette® 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
45
June 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy smokers, smoking at least 15 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 months 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
 
NCT01084603
NICTDP1065/A6431116, 2008-006280-36
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