Last updated: 11/04/2018 10:27:17
Comparison of pharmacokinetic profiles of two nicotine gum formulations
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A pharmacokinetic study comparing two nicotine gum formulations in a single dose design
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area under the curve from time 0 to time 't' [AUC(0-t)] of Nicotine 2 mg test and reference product
Timeframe: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg test and reference product
Timeframe: Blood samples to be collected from baseline to 12 hours post dose
Maximum observed concentration (Cmax) of Nicotine 2 mg test and reference product
Timeframe: Blood samples to be collected from baseline to 12 hours post dose
Cmax of Nicotine 4 mg test and reference product
Timeframe: Blood samples to be collected from baseline to 12 hours post-dose
Secondary outcomes:
Time to maximum observed concentration (Tmax) of Nicotine 2 mg test and reference products, and Nicotine 4 mg test and reference products
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Blood samples to be collected from baseline to 12 hours post dose
Interventions:
Drug: Nicotine (2 mg)
Drug: Nicotine (4 mg)
Enrollment:
84
Observational study model:
Not applicable
Primary completion date:
2013-30-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking Cessation
Product
nicotine
Collaborators
Not applicable
Study date(s)
May 2013 to June 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Location
Celerion - BELFAST
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-30-06
Actual study completion date
2013-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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