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Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg

NCT02621905 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-26

No results posted yet for this study

Summary

The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring anti-fungal prophylaxis or therapy. The present study is designed to compare the pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The 3-week exposure to each formulation is designed to allow for all participants to reach steady-state for each drug, as the time to steady-state can vary.

Conditions

Interventions

DRUG

Sporanox

At least 2 capsules twice a day for 3 weeks

DRUG

Lozanoc

At least 2 capsules twice a day for 3 weeks

Sponsors & Collaborators

  • Mayne Pharma International Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Deborah Marriott · St Vincent's Hospital, Sydney

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • Australia

Study Locations

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Entities

Diseases

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 NCT02621905 on ClinicalTrials.gov