Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01234792
First received: November 3, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.


Condition Intervention
Tobacco Dependence
Drug: 6 mg Experimental nicotine gum
Drug: 4 mg Nicotine Gum/
Drug: 2 mg Nicotine Gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - 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 Observed Plasma Concentration (Cmax) [ Time Frame: During 8 hours post-dose ] [ Designated as safety issue: No ]
    Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

  • Area Under the Curve (AUC)(0-t) [ Time Frame: During 8 hours post-dose ] [ Designated as safety issue: No ]
    AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).

  • AUC(0-∞) [ Time Frame: 8 hours post-dose ] [ Designated as safety issue: No ]
    AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.


Enrollment: 24
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIC-6
6 mg Experimental nicotine gum
Drug: 6 mg Experimental nicotine gum
A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
Other Name: Not marketed
Active Comparator: NIC-4
4 mg Nicotine Gum
Drug: 4 mg Nicotine Gum/
A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
Other Name: Nicorette® Gum
Active Comparator: NIC-2
2 mg Nicotine Gum
Drug: 2 mg Nicotine Gum
A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
Other Name: Nicorette® Gum

Detailed Description:

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and 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.

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.
  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: NCT01234792

Locations
Sweden
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-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: NCT01234792     History of Changes
Other Study ID Numbers: NICTDP1070, 2008-000596-15
Study First Received: November 3, 2010
Last Updated: July 6, 2012
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on October 19, 2014