drugset / Trial / NCT04212000
Bioavailability of Levoketoconazole and Ketoconazole Tablets
RandomizedCrossoverOpen-labelOther
Summary
This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).
Timeline
- Start
- 2019-12-16
- Primary completion
- 2020-01-18
- Completion
- 2020-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketoconazole | Small molecule | 200 mg | Oral |
| Subject | Levoketoconazole | Unknown | 150 mg | Oral |
Indications
No indication recorded.