NCT02230046 - Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants | Biotech Hunter

Enrollment

102

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions

Healthy

Interventions

DRUG

Abiraterone acetate (Treatment A)

Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

DRUG

Abiraterone acetate (Treatment B)

Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4\*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

DRUG

Abiraterone acetate (Treatment B)

Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2\*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

Trial Locations (1)

Unknown

Tempe

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY