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NCT03657290 · ClinicalTrials.gov registry record · Phase 1
A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet
A Phase 1 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT03657290 is a Phase 1 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 54 participants.
The verdict
NCT03657290, a Phase 1 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.
Interventions
- DRUG vadadustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2018-08-03 |
| Est. Completion | 2018-10-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03657290
The ClinicalTrials.gov registry entry for NCT03657290 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akebia Therapeutics, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vadadustat is the first listed.
NCT03657290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03657290 about?
NCT03657290 is a clinical study titled "A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet". This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.
What is the current status of trial NCT03657290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2018-08-03. Estimated completion is 2018-10-16.
What interventions are being tested in trial NCT03657290?
The interventions under investigation include: vadadustat (DRUG).
Who is sponsoring clinical trial NCT03657290?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
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