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Effect of Heat on Rivastigmine TDS Products

NCT03915626 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-04-04

Study results available
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Summary

This research study is designed to measure the amount of medicine in blood over time after the patch is placed on the skin with and without external heat application.

Conditions

  • Bioavailability

Interventions

DRUG

Rivastigmine (RLD) transdermal patch

brand name patch

DRUG

Rivastigmine (generic) transdermal patch

generic patch

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

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
2019-10-04
Primary Completion
2021-05-04
Completion
2021-05-04
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 NCT03915626 on ClinicalTrials.gov