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Bioavailability of Levoketoconazole and Ketoconazole Tablets

NCT04212000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-01-31

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

Levoketoconazole

Levoketoconazole tablet

DRUG

Ketoconazole

Ketoconazole tablet

Sponsors & Collaborators

  • Cortendo AB

    lead INDUSTRY

Principal Investigators

  • Xavier Valencia, MD · Cortendo AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-01-18
Completion
2020-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212000 on ClinicalTrials.gov