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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: Completed Phase 1 study, sponsored by Cortendo AB.
NCT04212000 is a Phase 1 study that has completed, run by Cortendo AB. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Point estimates and 90 percent (%) confidence intervals (CIs) for the dose-normalized ratios of geometric least squares means between Test (levoketoconazole) and Reference (ketoconazole)
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 |
What the finished NCT04212000 record still lists
NCT04212000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketoconazole is the first listed.
NCT04212000 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04212000's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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