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Pharmacokinetics of Metronidazole Dermal Products

NCT03271983 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-05-17

Study results available
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Summary

Generate human PK data by collecting data following the application of metronidazole formulations.

Conditions

  • Bioequivalence

Interventions

DRUG

Metronidazole gel 1

RLD gel

DRUG

Metronidazole gel 2

generic gel

DRUG

Metronidazole cream

generic cream

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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2019-10-31
Completion
2019-11-03
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 NCT03271983 on ClinicalTrials.gov