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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: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01640093 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pharmacokinetic parameter Cmax of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.
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 |
What the finished NCT01640093 record still lists
NCT01640093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01640093's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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