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NCT04212000 · ClinicalTrials.gov registry record · Phase 1

Bioavailability of Levoketoconazole and Ketoconazole Tablets

A Phase 1 study, sponsored by Cortendo AB.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT04212000 is a Phase 1 study that has completed, run by Cortendo AB. The registered enrollment target is 34 participants.

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The verdict

NCT04212000, a Phase 1 study, has completed, sponsored by Cortendo AB.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

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).

Interventions

  • DRUG Ketoconazole
  • DRUG Levoketoconazole

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2019-12-16
Est. Completion 2020-01-23
Phase Phase 1

Sponsor

Cortendo AB

6 total trials

What the Registry Record Tells You About NCT04212000

The ClinicalTrials.gov registry entry for NCT04212000 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cortendo AB, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ketoconazole is the first listed.

NCT04212000 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04212000 about?

NCT04212000 is a clinical study titled "Bioavailability of Levoketoconazole and Ketoconazole Tablets". 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).

What is the current status of trial NCT04212000?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-12-16. Estimated completion is 2020-01-23.

What interventions are being tested in trial NCT04212000?

The interventions under investigation include: Ketoconazole (DRUG), Levoketoconazole (DRUG).

Who is sponsoring clinical trial NCT04212000?

This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.