JCCT 195

A Two-period, Two-sequence, Two-treatment, Single-dose Crossover Study of Atropine Sulfate Ophthalmic Solution (1%) Administered Sublingually vs Atropine Sulfate Administered Intramuscularly for Bioequivalence Determination
18 - 65 / Male or Female / Earn up to $1,800

About the Study

This study will compare two different ways of giving a medicine called atropine to healthy adults. The goal of this study is to find out if atropine sulfate eye drops placed under the tongue are similar in their function to the injection form given in the thigh.

This research is a Bioequivalence – Bioavailability and pharmacokinetics (PK) study, meaning that this study is comparing how different forms of atropine sulfate (the study drug), specifically atropine sulfate eye drops delivered under the tongue (sublingually) and atropine sulfate injection form delivered using a needle into a muscle of your leg (intramuscular or IM), are similar by measuring the level of study drug that becomes completely available in the bloodstream; also, how the body processes and eliminates the study drug. The goal of this research is to find out if atropine sulfate eye drops placed under the tongue has a similar effectiveness in the body as the injected form of atropine given IM. Information learned from this study may help other people in the future.

Qualifications

Are you between 18 and 65?

Are you taking any prescription medication?

Are you able to attend visits at our clinic in Lenexa?

Are you able to pass a urine drug screen?

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Frequently asked questions

View all FAQs

What is a screening visit?

A screening visit is your first visit to our facility and takes roughly 2-4 hours. After filling out paperwork and reviewing a consent form, one of our nurses will go over the details to ensure your understanding.
This is the perfect time to ask any questions about the study and how your participation will affect you.
The nurse will then go over your medical history and take vitals.
The next step is completing a physical with our doctor. If our doctor deems you healthy enough for the study, you will then see our phlebotomist for a blood draw.

How do I prepare for my screening visit?

The night before:

  • Hydrate, hydrate, hydrate!
  • Avoid a large consumption of alcohol
  • Avoid sugary foods and drinks

The morning of:

  • Continue to hydrate well
  • Eat a light, healthy breakfast (Examples: bagels, scrambled eggs, yogurt, fruit, whole grain cereal)
  • Bring a photo ID
  • Make sure you have a form of entertainment (Examples: Books, magazines, mobile video game systems, laptops, etc.)

What questions should I ask the nurse?

First, you can ask our nurses any questions that come to your mind at any point of the process. But some good examples are:

  • Has this new medication/vaccine been tested on humans before?
  • What is the purpose of this new medication/vaccination?
  • What are the risks involved?
  • What company developed the medication/vaccine?
  • What is the procedure?
  • How/What samples are collected?
  • How long is the trial?

What is informed consent?

Informed consent is the process of our volunteers being given all the information about the study. For your protection, all clinical trial facilities MUST give you all the details (including risks and benefits) pertaining to the study before you give consent to volunteer. All volunteers must sign the informed consent before they can participate in a trial. As the study progresses, there could be additional informed consent forms that require your signature.

JCCT takes this process very seriously. You will be given 1 on 1 time with one of our nurses to go over the consent form and ask as many questions as you need before you sign.