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NCT01640093 · ClinicalTrials.gov registry record · Phase 1
A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01640093 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 32 participants.
The verdict
NCT01640093, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.
Interventions
- DRUG Abiraterone acetate, 250 mg (uncoated, current commercial tablet)
- DRUG Abiraterone acetate, 500 mg (coated, reformulated tablet)
- DRUG Abiraterone acetate, 250 mg (coated, reformulated tablet)
- DRUG Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01640093
The ClinicalTrials.gov registry entry for NCT01640093 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 Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Abiraterone acetate, 250 mg (uncoated, current commercial tablet) is the first listed.
NCT01640093 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01640093 about?
NCT01640093 is a clinical study titled "A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet". The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, und...
What is the current status of trial NCT01640093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01640093?
The interventions under investigation include: Abiraterone acetate, 250 mg (uncoated, current commercial tablet) (DRUG), Abiraterone acetate, 500 mg (coated, reformulated tablet) (DRUG), Abiraterone acetate, 250 mg (coated, reformulated tablet) (DRUG), Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution) (DRUG).
Who is sponsoring clinical trial NCT01640093?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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