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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
History of Changes
  Purpose

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


Condition Intervention Phase
Tobacco Dependence
 Drug: Nicotine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Other Name: Not yet marketed
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
 Drug: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Other Name: Nicorette® Freshfruit Gum
Experimental: NRT 90
A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
 Drug: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Other Name: Not yet marketed
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
 Drug: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Other Name: Nicorette® Freshfruit Gum
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
 Drug: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Other Name: NiQuitinTM Mint lozenge

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321931

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: NCT01321931     History of Changes
Other Study ID Numbers: NICTDP1081, 2010-023026-20
Study First Received: March 22, 2011
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:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013