Levoketoconazole Food Effect Study in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.

Clinical Trial Description

In each period of the randomized, two period crossover study, levoketoconazole will be administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal). Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in Period 2. ;

Study Design

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT03768388
Study type	Interventional
Source	Cortendo AB
Contact
Status	Completed
Phase	Phase 1
Start date	November 30, 2018
Completion date	December 24, 2018

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