CompletedPhase 4

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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03029650

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04

Results submitted2018-03-29

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