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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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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   (Adult)
Sexes Eligible for Study:   All
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
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: 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

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

Keywords provided by GlaxoSmithKline:
nicotine lozenge
nicotine
nicotine replacement therapy

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 17, 2017