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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

December 15, 2011
March 14, 2013
July 2011
August 2011   (final data collection date for primary outcome measure)
  • 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.
  • AUC0-t [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    low dose nicotine polacrilex mini cherry lozenge bioequivalent to low dose nicotine polacrilex mini mint lozenge and • higher dose nicotine polacrilex mini cherry lozenge bioequivalent to higher dose nicotine polacrilex mini mint lozenge
  • Cmax [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    Low dose nicotine polacrilex mini cherry lozenge bioequivalent to low dose nicotine polacrilex mini mint lozenge and • higher dose nicotine polacrilex mini cherry lozenge bioequivalent to higher dose nicotine polacrilex mini mint lozenge
Complete list of historical versions of study NCT01536704 on ClinicalTrials.gov Archive Site
  • 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.
  • AUC0-∞ [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    compare the low dose mini cherry lozenge to the low dose mini mint lozenge and compare higher dose mini cherry lozenge to the higher dose mini mint lozenge
  • tmax [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    compare the low dose mini cherry lozenge to the low dose mini mint lozenge and compare higher dose mini cherry lozenge to the higher dose mini mint lozenge
  • t½, [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    compare the low dose mini cherry lozenge to the low dose mini mint lozenge and compare higher dose mini cherry lozenge to the higher dose mini mint lozenge
  • Kel [ Time Frame: Blood samples taken immediately pre-dose and at 17 time points over a 12 hour period post dosing ] [ Designated as safety issue: Yes ]
    compare the low dose mini cherry lozenge to the low dose mini mint lozenge and compare higher dose mini cherry lozenge to the higher dose mini mint lozenge
Not Provided
Not Provided
 
Nicotine Lozenge Bioequivalence Study
A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Smoking Cessation
  • Drug: Nicotine (2 mg)
    2 mg nicotine lozenge in two formulations
  • Drug: Nicotine (4 mg)
    4 mg nicotine lozenge in two formulations
  • Experimental: Test nicotine lozenge (2 mg)
    2 mg test nicotine lozenge to be chewed.
    Intervention: Drug: Nicotine (2 mg)
  • Experimental: Test nicotine lozenge (4 mg)
    4 mg test nicotine lozenge to be chewed.
    Intervention: Drug: Nicotine (4 mg)
  • Active Comparator: Reference nicotine lozenge (2 mg)
    2 mg reference nicotine lozenge to be chewed.
    Intervention: Drug: Nicotine (2 mg)
  • Active Comparator: Reference nicotine lozenge (4 mg)
    4 mg reference nicotine lozenge to be chewed.
    Intervention: Drug: Nicotine (4 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01536704
S6491365
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP