Healthy Subjects Clinical Trial
Official title:
A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide)
formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the
safety and tolerability of oral formulations.
Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up
to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the
last pharmacokinetic (PK) sampling or after early withdrawal.
n/a
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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