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Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis

NCT00791219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2020-08-25

Study results available
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Summary

The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of onychomycosis of the toenail. Both the test and the reference formulations will also be compared to a placebo formulation to test for superiority.

Conditions

  • Onychomycosis

Interventions

DRUG

SUBA-itraconazole

100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)

DRUG

Itraconazole

200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).

DRUG

Placebo

Two placebo capsules taken approximately 30 minutes prior to breakfast

Sponsors & Collaborators

  • Halcygen Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Roger Aston · Halcygen Pharmaceuticals Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00791219 on ClinicalTrials.gov