A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01702519
First received: October 4, 2012
Last updated: April 25, 2013
Last verified: October 2012
  Purpose

Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.


Condition Intervention Phase
Smoking
Drug: nicotine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area under the curve from time 0 to the last quantifiable sample, AUC(0-t) [ Time Frame: Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. ] [ Designated as safety issue: No ]
    Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine.

  • Maximum Measured Plasma Concentration (Cmax) [ Time Frame: Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours. ] [ Designated as safety issue: No ]
    Maximum plasma nicotine concentration was determined from plasma concentration time profiles.


Secondary Outcome Measures:
  • Area under the concentration time curve between zero and infinity, AUC (0-inf) [ Time Frame: Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours. ] [ Designated as safety issue: No ]
    Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined

  • Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours. ] [ Designated as safety issue: No ]
    Tmax was determined from plasma concentration time profile.

  • Plasma half-life (t1/2), [ Time Frame: Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. ] [ Designated as safety issue: No ]
    The elimination half-life of drug was determined.

  • Rate of elimination (Kel) [ Time Frame: Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. ] [ Designated as safety issue: No ]
    Elimination rate constant for nicotine was calculated.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference
nicotine transdernal patch with the existing polyisobutylene adhesive
Drug: nicotine
nicotine transdermal patch
Active Comparator: Treatement
nicotine transdernal patch with the alternate polyisobutylene adhesive
Drug: nicotine
nicotine transdermal patch

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 19-27 kg/m2
  • smokes >10 cigarettes per day for preceeding 6 months

Exclusion Criteria:

  • inability to stop smoking during study
  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: NCT01702519

Locations
United States, Nebraska
Celerion NEBRASKA
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702519     History of Changes
Other Study ID Numbers: RH01418
Study First Received: October 4, 2012
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

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 September 22, 2014