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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2011

Last Updated Date

March 14, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01536704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nicotine Lozenge Bioequivalence Study

Official Title ^ICMJE

A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Drug: Nicotine (2 mg)
2 mg nicotine lozenge in two formulations
Drug: Nicotine (4 mg)
4 mg nicotine lozenge in two formulations

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01536704

Other Study ID Numbers ^ICMJE

S6491365

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2013

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

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