Status:
COMPLETED
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Lead Sponsor:
GlaxoSmithKline
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01847443
Start Date
May 1 2013
End Date
June 1 2013
Last Update
April 11 2014
Active Locations (1)
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1
Celerion - BELFAST
Belfast, Northern Ireland, United Kingdom, BT9 6AD