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NCT05665283 · ClinicalTrials.gov registry record · Phase 1
A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions
A Phase 1 study, sponsored by Xcovery Holdings.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05665283 is a Phase 1 study that has completed, run by Xcovery Holdings. The registered enrollment target is 32 participants.
The verdict
NCT05665283, a Phase 1 study, has completed, sponsored by Xcovery Holdings.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.
Interventions
- DRUG Ensartinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2023-08-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05665283
The ClinicalTrials.gov registry entry for NCT05665283 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xcovery Holdings, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ensartinib Hydrochloride is the first listed.
NCT05665283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05665283 about?
NCT05665283 is a clinical study titled "A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions". This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.
What is the current status of trial NCT05665283?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-11-29. Estimated completion is 2023-08-08.
What interventions are being tested in trial NCT05665283?
The interventions under investigation include: Ensartinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05665283?
This trial is sponsored by Xcovery Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.
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