drugset / Trial / NCT04212000

Bioavailability of Levoketoconazole and Ketoconazole Tablets

NCT04212000

Phase 1 Completed 34 enrolled Cortendo AB
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

EvaluationDrugModalityDoseRoute
Comparator Ketoconazole Small molecule 200 mg Oral
Subject Levoketoconazole Unknown 150 mg Oral

Indications

No indication recorded.