NCT04212000

Bioavailability of Levoketoconazole and Ketoconazole Tablets

A Phase 1 Randomized, Open-Label, Two-Period,Two-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Levoketoconazole and Ketoconazole Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Cortendo AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

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). Subjects will be randomized to receive a single oral dose of 150 mg levoketoconazole (Study Drug A) or a single oral dose of 200 mg ketoconazole (Study Drug B) in each period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Levoketoconazole	Levoketoconazole tablet
DRUG	Ketoconazole	Ketoconazole tablet

Timeline

• Start date: 2019-12-16
• Primary completion: 2020-01-18
• Completion: 2020-01-23
• First posted: 2019-12-26
• Last updated: 2020-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study