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NCT01598363 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01598363 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 32 participants.
The verdict
NCT01598363, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.
Interventions
- DRUG Rosuvastatin
- DRUG Digoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-06-30 |
| Est. Completion | 2012-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01598363
The ClinicalTrials.gov registry entry for NCT01598363 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 Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rosuvastatin is the first listed.
NCT01598363 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01598363 about?
NCT01598363 is a clinical study titled "An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers". The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.
What is the current status of trial NCT01598363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-06-30. Estimated completion is 2012-07-31.
What interventions are being tested in trial NCT01598363?
The interventions under investigation include: Rosuvastatin (DRUG), Digoxin (DRUG).
Who is sponsoring clinical trial NCT01598363?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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