- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847443
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
March 6, 2014 updated by: GlaxoSmithKline
A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northern Ireland
-
Belfast, Northern Ireland, United Kingdom, BT9 6AD
- Celerion - BELFAST
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI within the range of 19 to 30 kilograms/meters^2
- Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up
Exclusion Criteria:
- Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
- Treatment with known hepatic enzyme altering agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test nicotine gum (2 mg)
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
2 mg nicotine gum in two formulations
|
Experimental: Test nicotine gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
4 mg nicotine gum in two formulations
|
Active Comparator: Reference nicotine gum (2 mg)
A single dose of reference nicotine gum (2 mg) to be chewed.
|
2 mg nicotine gum in two formulations
|
Active Comparator: Reference nicotine gum (4 mg)
A single dose of reference nicotine gum (4 mg) to be chewed.
|
4 mg nicotine gum in two formulations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
AUC(0-t) of Nicotine 4 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
Cmax for 2 mg test was compared with 2 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Cmax of Nicotine 4 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post-dose
|
Cmax for 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
|
AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
|
Blood samples to be collected from baseline to 12 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 2, 2013
First Submitted That Met QC Criteria
May 2, 2013
First Posted (Estimate)
May 6, 2013
Study Record Updates
Last Update Posted (Estimate)
April 11, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RH01705
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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