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

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ClinicalTrials.gov Identifier: NCT01084603
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : July 8, 2010
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

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

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Oral Nicotine Drug: NiQuitinTM Nicotine Lozenge Drug: Nicorette® Nicotine Gum Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oral Nicotine 1
One oral administration of 1 mg nicotine
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
Experimental: Oral Nicotine 2
Two oral administrations of 1 mg nicotine
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
Experimental: Oral Nicotine 4
Four oral administrations of 1 mg nicotine
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
Active Comparator: NiQuitinTM Nicotine Lozenge 4 mg
One 4 mg marketed nicotine lozenge
Drug: NiQuitinTM Nicotine Lozenge
A marketed 4 mg Nicotine lozenge
Other Name: NiQuitinTM lozenge
Active Comparator: Nicorette® Gum 4 mg
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
Drug: Nicorette® Nicotine Gum
A marketed 4 mg Nicotine Gum
Other Name: Nicorette® gum



Primary Outcome Measures :
  1. Maximum Plasma Concentration [ Time Frame: During 12 hours after start of administration ]
    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)

  2. Bioavailability [ Time Frame: 12 hours ]
    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).


Secondary Outcome Measures :
  1. Nicotine Plasma Concentration [ Time Frame: During 10 minutes after start of administration ]
    Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)

  2. Time of Maximum Concentration [ Time Frame: During 12 hours after start of administration ]
    The time at which maximum concentration is reached (Tmax)

  3. Terminal Elimination Rate Constant [ Time Frame: During 12 hours after start of administration ]
    The terminal nicotine elimination rate constant (Lamda z)

  4. Released Nicotine [ Time Frame: After 30 minutes' chewing ]
    The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01084603


Locations
Sweden
Clinical Pharmacology
Lund, Sweden, 222 20
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB

Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT01084603     History of Changes
Other Study ID Numbers: NICTDP1065/A6431116
2008-006280-36 ( EudraCT Number )
First Posted: March 10, 2010    Key Record Dates
Results First Posted: July 8, 2010
Last Update Posted: July 13, 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