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A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants

NCT01678573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-09-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Treatment A: abiraterone acetate

250 mg/day tablet administered orally on Day 1 of each treatment period.

DRUG

Treatment B: abiraterone acetate

500 mg/day tablets administered orally on Day 1 of each treatment period.

DRUG

Treatment C: abiraterone acetate

1000 mg/day tablets administered orally on Day 1 of each treatment period.

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
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • China

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 NCT01678573 on ClinicalTrials.gov