Nicotine Lozenge Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01536704
First received: December 15, 2011
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.


Condition Intervention Phase
Smoking Cessation
Drug: Nicotine (2 mg)
Drug: Nicotine (4 mg)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    AUC(0-t) was evaluated using the trapezoid rule.

  • Maximum Observed Plasma Concentration [Cmaximum (Max)] [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    Cmax was depicted from plasma concentration of nicotine.


Secondary Outcome Measures:
  • AUC [0-infinity (Inf)] [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    AUC (0-inf) was evaluated using the trapezoid rule.

  • Time to Reach Maximum Plasma Nicotine Concentration (Tmax) [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    Tmax was time at which Cmax of nicotine was reached.

  • Apparent Elimination Half-life of Nicotine T(1/2) [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    T(1/2) was calculated using plasma time-concentration values.

  • Elimination Rate Constant for Plasma Nicotine: K (el) [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
    Kel was calculated with the help of plasma time concentration values.


Enrollment: 50
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test nicotine lozenge (2 mg)
2 mg test nicotine lozenge to be chewed.
Drug: Nicotine (2 mg)
2 mg nicotine lozenge in two formulations
Experimental: Test nicotine lozenge (4 mg)
4 mg test nicotine lozenge to be chewed.
Drug: Nicotine (4 mg)
4 mg nicotine lozenge in two formulations
Active Comparator: Reference nicotine lozenge (2 mg)
2 mg reference nicotine lozenge to be chewed.
Drug: Nicotine (2 mg)
2 mg nicotine lozenge in two formulations
Active Comparator: Reference nicotine lozenge (4 mg)
4 mg reference nicotine lozenge to be chewed.
Drug: Nicotine (4 mg)
4 mg nicotine lozenge in two formulations

  Eligibility

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

Inclusion Criteria:

  • Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
  • Body Mass Index within the range 19-27 kilograms/meters^2

Exclusion Criteria:

  • Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536704

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: NCT01536704     History of Changes
Other Study ID Numbers: S6491365
Study First Received: December 15, 2011
Results First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
nicotine lozenge
nicotine
nicotine replacement therapy

Additional relevant MeSH terms:
Smoking
Habits
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 April 15, 2014