Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05164367
Brief Summary:
To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.
Detailed Description:
This study is a single-dose, single-center, open-label study of the pharmacokinetics of atropine gel (0.01% w/w) after topical oral administration in healthy adults. Study participants will be recruited by Drs. Murphy, Darro, and Yellepeddi at the Center for Clinical and Translation Science (CCTS), University of Utah. Participants who meet eligibility criteria will be recruited in the study after signing informed consent. Each of the 10 participants will receive 1 gram of atropine gel (0.01% w/w) containing 0.1 mg atropine via self-administration of gel into the oral cavity. Dr. Yellepeddi is a licensed pharmacist in the State of Utah and will train subjects in the administration of atropine gel in the oral cavity. A series of timed blood samples (0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours, 7 mL each time point) will be collected in commercial tubes, and plasma will be separated by centrifugation. The plasma samples will be stored frozen until further analysis by the Center for Human Toxicology (CHT), University of Utah.
Study:
NCT05164367
Study Brief:
Protocol Section:
NCT05164367