Last updated: 11/04/2018 10:41:28
A Pharmacokinetic Evaluation of Nicotine Patches in Smokers
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Pharmacokinetic Evaluation of Nicotine Patches in Smokers
Trial description: A Pharmacokinetic Evaluation of Nicotine Patches in Smokers
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area under the curve (AUC 0-infinity)
Timeframe: 1 day
Secondary outcomes:
Adverse events
Timeframe: over course of study
Topical effects
Timeframe: over course of study
Other PK variables
Timeframe: 1 day
Interventions:
Not applicable
Enrollment:
50
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking
Product
nicotine
Collaborators
Not applicable
Study date(s)
May 2009 to June 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
19 - 55 Year
Accepts healthy volunteers
none
- Weight: Body Mass Index (BMI) within the range 19-27kg/m2 [BMI=weight in kilograms (kg) ÷ height in meters squared (m2)].
- Smoking status
- Disease: a. Presence of any disease or condition which may interfere with the transdermal absorption of the study drugs. b. A disease or condition (including, but not limited to, excessive hair, skin, scarring, or tattoos) at the site of patch application that may interfere with transdermal absorption of the study drugs or with visual evaluation of the patch site. The topical effect rating of the patch site should be zero at the baseline evaluation for subjects to be dosed. c.A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject, e.g., recent myocardial infarction or cerebrovascular accident (i.e., within 12 weeks prior to the first study session), unstable or worsening angina pectoris, Prinzmetal’s angina, severe cardiac arrhythmia.
- d. A medical history, which, in the opinion of the investigator, might impact the validity of the study results, may require treatment, or make the subject unlikely to finish the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Weight: Body Mass Index (BMI) within the range 19-27kg/m2 [BMI=weight in kilograms (kg) ÷ height in meters squared (m2)].
- Smoking status Admits to smoking more than 10 cigarettes per day for the preceding 6 months (prior to initial dose).
Exclusion criteria:
- Disease: a. Presence of any disease or condition which may interfere with the transdermal absorption of the study drugs. b. A disease or condition (including, but not limited to, excessive hair, skin, scarring, or tattoos) at the site of patch application that may interfere with transdermal absorption of the study drugs or with visual evaluation of the patch site. The topical effect rating of the patch site should be zero at the baseline evaluation for subjects to be dosed. c.A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject, e.g., recent myocardial infarction or cerebrovascular accident (i.e., within 12 weeks prior to the first study session), unstable or worsening angina pectoris, Prinzmetal’s angina, severe cardiac arrhythmia. d. A medical history, which, in the opinion of the investigator, might impact the validity of the study results, may require treatment, or make the subject unlikely to finish the study.
- Smoking: Inability to abstain from smoking or use of other tobacco products during each study session (from start of baseline to the completion of the last PK blood sampling at 8 hours after the final dose). CO measurement immediately prior to dosing should be less than or equal to 10 parts per million (ppm) for the subject to be dosed.
- Blood: a. Has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2. b. Hemoglobin value < 12.0 g/dL.
- Medications: a. Has been treated with any known enzyme altering agents (e.g., barbiturates, phenothiazines, cimetidine, theophyllines) within 30 days prior to the first study session. b.Has used any nicotine replacement therapy within 21 days prior to the first study session. c.Has used any over-the-counter (OTC) medication, including herbal supplements, within 48 hours prior to administration of study treatment. d Has used any prescription medication within 14 days prior to dosing, excluding hormonal contraceptive or hormone replacement therapy.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-05-06
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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