Scopolamine Patch Pharmacokinetics in Healthy Adults
United States26 participantsStarted 2016-11
Plain-language summary
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 of Transderm Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of individuals utilizing these types of products.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men or non-pregnant women of any ethnic background between the age of 18 and 65 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 12 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 18-29.9 kg/m2).
✓. Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
Exclusion criteria
✕. Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any procedure session.
✕. Smokers (current use or use over the previous 12 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)).
What they're measuring
1
Measurement of Maximum Serum Concentration of Scopolamine (Cmax)
Timeframe: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
✕. Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow up phase and it has been ≥ 1 month since the subject received any experimental agents or treatments..
✕. Abnormal vital signs, defined as:
✕. Temperature \>38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the scopolamine TDDS.
✕. History of chronic obstructive pulmonary disease.
✕. Positive urine drug screening test.
✕. Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications not included).