Overview

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

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayne Pharma International Pty Ltd
Treatments:
Hydroxyitraconazole
Itraconazole
Criteria
Inclusion Criteria:

- Provision of written, informed consent

- Age of at least 18 years

- No clinical evidence of active systemic fungal infection

- Physician-recommended primary prophylaxis against systemic fungal infections with
itraconazole in patients who have had or about to have: a heart, lung or bone marrow
transplant, combination chemotherapy for cancer; aspergilloma, chronic pulmonary
aspergillus bronchitis, or allergic bronchopulmonary aspergillosis

- Patients may be receiving itraconazole prophylaxis prior to entry into the study

- Body mass index between 15.0 and 35.0 kg/m2

Exclusion Criteria:

- Pregnant, planning pregnancy or breastfeeding

- Congestive cardiac failure or other causes of ventricular dysfunction that may
outweigh the benefit of itraconazole

- Hypersensitivity to either study drug or to any of their excipients

- Coadministration of the following drugs:

- CYP3A4 metabolised substrates that can prolong the QT-interval e.g., sertindole,
terfenadine

- CYP3A4 metabolised HMG-CoA reductase inhibitors e.g. simvastatin, lovastatin

- Potent CYP3A4 inhibitors e.g. dronedarone

- Triazolam, alprazolam and oral midazolam

- Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine) and
ergotamine