NCT01702519

Brief Summary

Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2015

Completed
Last Updated

March 20, 2015

Status Verified

February 1, 2015

Enrollment Period

Same day

First QC Date

October 4, 2012

Results QC Date

September 5, 2013

Last Update Submit

March 19, 2015

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)

    Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.

    Baseline to 32 hours

  • Maximum Measured Plasma Concentration (Cmax)

    Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.

    Baseline to 32 hours

Secondary Outcomes (4)

  • Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)

    Baseline to 32 hours

  • Time to Maximum Plasma Concentration (Tmax)

    Baseline to 32 hours

  • Plasma Half-life (t1/2)

    Baseline to 32 hours

  • Rate of Elimination (Kel)

    Baseline to 32 hours

Study Arms (2)

Reference

ACTIVE COMPARATOR

nicotine transdermal patch with the existing polyisobutylene adhesive

Drug: nicotine

Treatement

ACTIVE COMPARATOR

nicotine transdermal patch with the alternate polyisobutylene adhesive

Drug: nicotine

Interventions

nicotineDRUG

nicotine transdermal patch

ReferenceTreatement

Eligibility Criteria

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

You may qualify if:

  • BMI 19-27 kg/m2
  • smokes \>10 cigarettes per day for preceeding 6 months

You may not qualify if:

  • inability to stop smoking during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion NEBRASKA

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 8, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 20, 2015

Results First Posted

February 11, 2015

Record last verified: 2015-02

Locations

US(1)