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Pharmacokinetics of Atropine Oral Gel

NCT05164367 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-18

No results posted yet for this study

Summary

To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.

Conditions

  • Cerebral Palsy
  • Sialorrhea

Interventions

DRUG

Atropine sulfate gel (0.01%)

A research nurse will measure 1 gram of gel using a calibrated measuring spoon and will provide it to the participant for self-administration.

Sponsors & Collaborators

Principal Investigators

  • Venkata K. Yellepeddi, PhD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-06-30
Completion
2024-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164367 on ClinicalTrials.gov