drugset / Trial / NCT02621905
Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Itraconazole | Small molecule | 100 mg | — |
| Comparator | Itraconazole | Small molecule | 200 mg | — |