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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2020-01-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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