Last updated: 11/04/2018 10:26:17
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Area under the curve from time 0 to the last quantifiable sample, AUC(0-t)
Timeframe: Baseline to 32 hours
Maximum Measured Plasma Concentration (Cmax)
Timeframe: Baseline to 32 hours
Secondary outcomes:
Area under the concentration time curve between zero and infinity, AUC (0-inf)
Timeframe: Baseline to 32 hours
Time to Maximum Plasma Concentration (Tmax)
Timeframe: Baseline to 32 hours
Plasma half-life (t1/2)
Timeframe: Baseline to 32 hours
Rate of elimination (Kel)
Timeframe: Baseline to 32 hours
Interventions:
Drug: nicotine
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
2012-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking
Product
nicotine
Collaborators
Not applicable
Study date(s)
March 2012 to March 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
19 - 55 years
Accepts healthy volunteers
Yes
- BMI 19-27 kg/m2
- smokes >10 cigarettes per day for preceeding 6 months
- inability to stop smoking during study
Inclusion and exclusion criteria
Inclusion criteria:
- BMI 19-27 kg/m2
- smokes >10 cigarettes per day for preceeding 6 months
Exclusion criteria:
- inability to stop smoking during study
Trial location(s)
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
2012-31-03
Actual study completion date
2012-31-03
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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