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PK and DPK of Lidocaine Dermal Products

NCT03145207 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-07-09

Study results available
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Summary

This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.

Conditions

  • Heat Effect

Interventions

DRUG

Lidocaine patch

lidocaine patch

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

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

  • Hazem 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
2016-12-14
Primary Completion
2019-01-10
Completion
2020-05-15
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 NCT03145207 on ClinicalTrials.gov