Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01228617
First received: October 25, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.


Condition Intervention
Tobacco Dependence
Drug: Nicotine
Drug: Nicotine Gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Concentration [ Time Frame: Baseline to 10 hours post-dose ] [ Designated as safety issue: No ]
    The maximum observed nicotine concentration in plasma (Cmax)

  • Area under the Curve [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)


Secondary Outcome Measures:
  • Time to Maximum Concentration [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    Time to Maximum Concentration (Tmax)

  • Residual Nicotine [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The amount of residual nicotine in the product after being chewed.

  • Dissolution Time [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
    Actual time required for oral dissolution of new NRT products following product administration


Enrollment: 40
Study Start Date: September 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Short, no buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Experimental: A2 Short, low buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Experimental: A3 Short, high buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Experimental: B1 Long, no buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Experimental: B2 Long, low buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Experimental: B3 Long, high buffer
Nicotine / not yet marketed
Drug: Nicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Other Name: Not yet marketed
Active Comparator: R = Nicotine Gum
Nicorette® Gum
Drug: Nicotine Gum
Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
Other Name: Nicorette®

Detailed Description:

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

  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 10 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 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: NCT01228617

Locations
Sweden
Clinical Trial Unit, Clinical Research and Trial Centre
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01228617     History of Changes
Other Study ID Numbers: A6431114-NICTDP1063
Study First Received: October 25, 2010
Last Updated: October 4, 2011
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 July 22, 2014