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Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products

NCT03205605 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-04-11

Study results available
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Summary

This research study is intended to determine the effect of heat and occlusion on oxybutynin products.

Conditions

  • Heat Effect

Interventions

DRUG

oxybutynin

patch

DRUG

oxybutynin

gel

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Audra L Stinchcomb, PhD · University of Maryland Baltimore School of Pharmacy

  • Hazem E Hassan, PhD · University of Maryland Baltimore School of Pharmacy

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2019-11-13
Completion
2019-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03205605 on ClinicalTrials.gov