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
  Purpose

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


Condition Intervention
Tobacco Dependence
Drug: Oral Nicotine
Drug: NiQuitinTM Nicotine Lozenge
Drug: Nicorette® Nicotine Gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 45
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084603

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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01084603     History of Changes
Other Study ID Numbers: NICTDP1065/A6431116, 2008-006280-36
Study First Received: March 9, 2010
Results First Received: April 16, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation
Nicotine pharmacokinetics

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014