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Fentanyl Patch Pharmacokinetics in Healthy Adults

NCT02531971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-26

Study results available
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Summary

The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.

Conditions

  • Peer Review, Research

Interventions

DRUG

Intravenous fentanyl citrate

100 micrograms (2 millilitres) via intravenous injection

DRUG

Duragesic®

TDDS dosage is 25 micrograms/hour (worn for 72 h)

DRUG

Mylan generic fentanyl

TDDS dosage is 25 micrograms/hour (worn for 72 h)

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

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

  • Hazem Hassan, PhD · Univerisity of Maryland, School of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2018-10-16
Completion
2018-10-16
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 NCT02531971 on ClinicalTrials.gov