drugset / Trial / NCT02621905

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

NCT02621905

Phase 4 Completed 40 enrolled Mayne Pharma International Pty Ltd
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2015-11
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Itraconazole Small molecule 100 mg
Comparator Itraconazole Small molecule 200 mg

Indications