The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
✓. 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
✓. 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 protocol schedule, study restrictions and examination schedule
✓. Subjects who are within their ideal body weight (BMI between \>17 and ≤28 kg/m2)
✓. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
Exclusion criteria
✕. Women who are pregnant, lactating or breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any study session
✕. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g. cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)
What they're measuring
1
Area Under the Curve (AUC 0-∞ ) ng∙h/mL
Timeframe: 10 procedure days for Duragesic and Mylan arms each
. Participation in any ongoing investigational drug trial/study or clinical drug trial/study
✕. History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
✕. Active positive Hepatitis B, C and HIV serologies
✕. Positive urine drug screening test
✕. Use of any prescription medication during the session 0 to 30 days or over-the counter medication e.g. antihistamines or topical corticosteroids (vitamin, herbal supplements and birth control medications not included) during the session 0 to 3 days before entry to the study
✕. Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product or agents deemed to be immunosuppressive as determined by physician investigator with 72 hours prior to dosing (e.g. antihistamines, systemic or topical corticosteroids (within 3 weeks prior to dosing), cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)