NCT01897389View on ClinicalTrials.gov

A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Healthy Volunteers
Interventions
DRUG

Treatment A

1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions

DRUG

Treatment B

1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment C

1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment D

1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment E

1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

Trial Locations (1)

Unknown

Tempe

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01897389 - A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants | Biotech Hunter | Biotech Hunter