Single-dose Nicotine Pharmacokinetics With Four 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:
NCT01234896
First received: November 3, 2010
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.


Condition Intervention
Tobacco Dependence
Drug: Nicotine Medicated Gum
Drug: 4 mg Nicotine Gum
Drug: 2 mg Nicotine Gum
Drug: 4 mg Nicotine Lozenge

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 Four 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: 12 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: 12 hours post-dose ] [ Designated as safety issue: No ]
    AUC(0-t), which is the area under the plasma concentration verses 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: 12 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.


Secondary Outcome Measures:
  • AUC(10 min) [ Time Frame: 10 minutes post-dose ] [ Designated as safety issue: No ]
    AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes


Enrollment: 44
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine Gum 6
6 mg Nicotine medicated gum
Drug: Nicotine Medicated Gum
Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
Other Name: Not marketed
Active Comparator: Nicotine Gum 4
4 mg Nicotine Gum
Drug: 4 mg Nicotine Gum
Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
Other Name: Nicorette® Freshfruit gum
Active Comparator: Nicotine Gum 2
2 mg Nicotine Gum
Drug: 2 mg Nicotine Gum
Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
Other Name: Nicorette® Freshfruit gum
Active Comparator: Nicotine Lozenge
4 mg Nicotine Lozenge
Drug: 4 mg Nicotine Lozenge
Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved
Other Name: NiQuitin™ Mint lozenge

Detailed Description:

Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

  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 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms.
  • 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: NCT01234896

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: NCT01234896     History of Changes
Other Study ID Numbers: NICTDP1080, 2010-021087-15
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
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 21, 2014