NCT01536704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2013

Completed
Last Updated

April 26, 2013

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

December 15, 2011

Results QC Date

March 14, 2013

Last Update Submit

March 14, 2013

Conditions

Smoking Cessation

Keywords

nicotine lozengenicotinenicotine replacement therapy

Outcome Measures

Primary Outcomes (2)

  • Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]

    AUC(0-t) was evaluated using the trapezoid rule.

    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

  • Maximum Observed Plasma Concentration [Cmaximum (Max)]

    Cmax was depicted from plasma concentration of nicotine.

    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

Secondary Outcomes (4)

  • AUC [0-infinity (Inf)]

    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

  • Time to Reach Maximum Plasma Nicotine Concentration (Tmax)

    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

  • Apparent Elimination Half-life of Nicotine T(1/2)

    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

  • Elimination Rate Constant for Plasma Nicotine: K (el)

    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

Study Arms (4)

Test nicotine lozenge (2 mg)

EXPERIMENTAL

2 mg test nicotine lozenge to be chewed.

Drug: Nicotine (2 mg)

Test nicotine lozenge (4 mg)

EXPERIMENTAL

4 mg test nicotine lozenge to be chewed.

Drug: Nicotine (4 mg)

Reference nicotine lozenge (2 mg)

ACTIVE COMPARATOR

2 mg reference nicotine lozenge to be chewed.

Drug: Nicotine (2 mg)

Reference nicotine lozenge (4 mg)

ACTIVE COMPARATOR

4 mg reference nicotine lozenge to be chewed.

Drug: Nicotine (4 mg)

Interventions

Nicotine (2 mg)DRUG

2 mg nicotine lozenge in two formulations

Reference nicotine lozenge (2 mg)Test nicotine lozenge (2 mg)
Nicotine (4 mg)DRUG

4 mg nicotine lozenge in two formulations

Reference nicotine lozenge (4 mg)Test nicotine lozenge (4 mg)

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion NEBRASKA

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

February 22, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 26, 2013

Results First Posted

April 26, 2013

Record last verified: 2013-03

Locations

US(1)