Determination of Plasma Nicotine Levels After Using Reference and Generic Transdermal Nicotine Patches With and Without Standardized Heat Application in Adult Smokers
Overview
- Phase
- Phase 4
- Intervention
- Nicoderm patch first, then Aveva patch
- Conditions
- Smoking
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Measurement of Maximum Serum Concentration (Cmax)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers.
Detailed Description
This research study is intended to determine the effect of heat on FDA-approved nicotine transdermal patches and whether the heat applied will result in more nicotine being absorbed through the skin than without applying heat. This is important given that little is known about how the release of nicotine is affected by heat, particularly for generic products that are also available over the counter. This study will use nicotine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold over the counter to customers in the United States, and will not include any placebos.
Investigators
Audra Stinchcomb
Principal Investigator
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
- •Subjects should be cigarette smokers who smoke at least 5 cigarettes per day for one year or more.
- •Provide written informed consent before initiation of any study procedures.
- •Available for follow-up for the planned duration of the study
- •Able to communicate well with the investigators
- •Able to adhere to the study restrictions and examination schedule.
- •Subjects who are within their ideal body weight (BMI \>17 and \<= 25)
- •Demonstrate comprehension of the protocol procedures and knowledge of study by passing (\>70% correct responses) a written examination containing 20 multiple choice and true false questions covering all aspects of the study including the purpose, procedures, risks and benefits.
- •Subjects deemed to be eligible as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
- •Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm),
Exclusion Criteria
- •Subjects who are nonsmokers or smoke less than 5 cigarettes per day
- •Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
- •Participation in any ongoing investigational drug trial or clinical drug trial
- •Abnormal Vital signs, defined as:
- •Hypertension (systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg) at rest on 2 separate days)
- •Heart rate \<55 at rest on 2 separate days
- •Respiratory rate \>20
- •Temperature \> 38.0 ºC (100.4 ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of the transdermal patch.
- •Active positive Hepatitis B, C, and HIV serologies
- •Positive urine drug screening test
Arms & Interventions
Nicoderm patch first, then Aveva patch
Each subject gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
Intervention: Nicoderm patch first, then Aveva patch
Outcomes
Primary Outcomes
Measurement of Maximum Serum Concentration (Cmax)
Time Frame: four procedure days for each participant
The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)
Secondary Outcomes
- AUC(0-12 h for each of the four procedure day)