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

NCT01640093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640093 on ClinicalTrials.gov