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Anticholinergic

Pharmacokinetics Study of Atropine Oral Gel

Phase < 1
Waitlist Available
Led By Venkata K. Yellepeddi, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the auc will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Awards & highlights

Study Summary

This trial looks at how atropine gel is absorbed into the bloodstream after being applied to the mouth.

Who is the study for?
This trial is for healthy adults who can consent in English and have no oral deformities, history of severe allergies to atropine or similar compounds, recent investigational drug use, immune suppression, tracheostomy, pregnancy/nursing status, severe kidney issues, liver diseases, gastrointestinal obstructions, active infections or treatments for them. Also excluded are those with chronic lung disease/COPD, on certain medications like MAO inhibitors or anticholinergics; with urinary retention; acute glaucoma; heart conditions; or recent cancer treatments.Check my eligibility
What is being tested?
The study tests how a single dose of Atropine sulfate gel (0.01%) behaves in the body after being applied inside the mouth of healthy adults. It aims to understand the absorption and clearance process of this medication when used as an oral gel.See study design
What are the potential side effects?
Potential side effects may include dry mouth due to reduced saliva production since atropine blocks certain nerve signals responsible for salivation. Other possible reactions could be related to its anticholinergic properties such as blurred vision if it affects the eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the tmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the tmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate pharmacokinetic parameter area under the curve (AUC) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Evaluate pharmacokinetic parameter clearance (CL) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Cmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 0.1 mg of atropineExperimental Treatment1 Intervention
1 gram of gel by topical application in the oral cavity once.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,339 Total Patients Enrolled
Venkata K. Yellepeddi, PhDPrincipal InvestigatorUniversity of Utah

Media Library

Atropine sulfate gel (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05164367 — Phase < 1
Drooling Research Study Groups: 0.1 mg of atropine
Drooling Clinical Trial 2023: Atropine sulfate gel Highlights & Side Effects. Trial Name: NCT05164367 — Phase < 1
Atropine sulfate gel (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05164367 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research investigations that have utilized Atropine sulfate gel (0.01%)?

"At this juncture, 6 investigations of Atropine sulfate gel (0.01%) are in their final Phase 3 and a total of 22 trials are operating globally; with the majority based out of Shanghai, China. Currently 149 medical facilities host clinical trial for Atropine sulfate gel (0.01%)."

Answered by AI

Does the protocol for this research project include participants under 85 years of age?

"The age parameters of this investigation necessitate participants to be above 18 years old, but younger than 50."

Answered by AI

In what clinical circumstances is Atropine sulfate gel (0.01%) typically utilized?

"Atropine sulfate gel (0.01%) is a useful intervention for managing ailments such as laughter, pupillary dilation and rhinorrhoea."

Answered by AI

Am I eligible for enrollment in this experiment?

"Eligibility for this research requires that applicants possess cerebral palsy and be within the ages 18-50. Approximately 10 participants will be admitted to the trial."

Answered by AI

How many participants are engaged with this clinical examination?

"Yes, according to clinicaltrials.gov, this medical research is actively recruiting patients. It was initially posted on October 1st 2022 and subsequently amended on November 1st 2022 with the goal of enrolling 10 participants at a single site."

Answered by AI

Are there still vacancies for this clinical trial?

"Per information on clinicaltrials.gov, this medicinal investigation is actively in search of participants. This trial was initially posted on the 1st October 2022 and most recently updated on the 1st November 2022."

Answered by AI
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~4 spots leftby Mar 2025