A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Healthy Participants
Interventions
DRUG

Abiraterone acetate, 250 mg (uncoated, current commercial tablet)

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.

DRUG

Abiraterone acetate, 500 mg (coated, reformulated tablet)

Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.

DRUG

Abiraterone acetate, 250 mg (coated, reformulated tablet)

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.

DRUG

Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)

Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.

Trial Locations (1)

Unknown

Tempe

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01640093 - A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet | Biotech Hunter | Biotech Hunter