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Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

NCT02394340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-27

Study results available
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Summary

This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Conditions

  • Tinea Pedis
  • Tinea Cruris

Interventions

DRUG

Omeprazole 40 mg

Oral capsule to be taken as per the instructions regarding proper dosing technique.

DRUG

Luliconazole Cream 1%

Topical cream to be applied as per the instructions regarding proper study drug application technique.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Anya Loncaric · Bausch Health Americas, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-03
Primary Completion
2015-04-01
Completion
2015-04-01

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 NCT02394340 on ClinicalTrials.gov