Completed
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
What is being tested
nicotine
+ nicotine
Drug
Who is being recruted
Behavior
+ Smoking
From 19 to 55 Years
+3 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: March 2012
Summary
Principal SponsorGlaxoSmithKline
Last updated: March 20, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorGlaxoSmithKline
Last updated: March 20, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 19 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorSmoking
Criteria
2 inclusion criteria required to participate
BMI 19-27 kg/m2
smokes > 10 cigarettes per day for preceeding 6 months
1 exclusion criteria prevent from participating
inability to stop smoking during study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active Comparatornicotine transdermal patch with the existing polyisobutylene adhesive
Group II
Active Comparatornicotine transdermal patch with the alternate polyisobutylene adhesive
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center