Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy … (NCT02486016) | Clinical Trial Compass
CompletedPhase 4
Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults
United States10 participantsStarted 2015-07-09
Plain-language summary
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* 1\. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old.
* 2\. Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
* 3\. Provide written informed consent before initiation of any study procedures.
* 4\. Available for follow-up for the planned duration of the study.
* 5\. Able to communicate well with the investigators.
* 6\. Able to adhere to the study protocol schedule.
* 7\. Subjects who are within their ideal body weight (BMI\>17 and ≤ 28).
* 8\. 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.
* 9\. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
* 10\. Negative urine drug screening test.
* 11\. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
* 12\. Have normal screening laboratories for WBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST and total bili…
What they're measuring
1
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic)
Timeframe: six procedure days for each participant