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A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation Under Fasted Condition in Healthy Adult Subjects
The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected.
Details
| Lead sponsor | Cougar Biotechnology, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2011-05 |
| Completion | 2011-06 |
Conditions
- Healthy Volunteers
Interventions
- Abiraterone acetate suspension Formulation 1
- Abiraterone acetate suspension Formulation 2
- Abiraterone acetate tablets
Primary outcomes
- Levels of study drug — Up to 55 days