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NCT03964038 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03964038 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 48 participants.
The verdict
NCT03964038, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants.
Interventions
- DRUG gilteritinib
- DRUG gilteritinib mini tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03964038
The ClinicalTrials.gov registry entry for NCT03964038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which gilteritinib is the first listed.
NCT03964038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03964038 about?
NCT03964038 is a clinical study titled "A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects". The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants.
What is the current status of trial NCT03964038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-05-21. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03964038?
The interventions under investigation include: gilteritinib (DRUG), gilteritinib mini tablet (DRUG).
Who is sponsoring clinical trial NCT03964038?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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