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A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers

NCT01362764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-11-27

No results posted yet for this study

Summary

The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Abiraterone acetate suspension Formulation 1

Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL

DRUG

Abiraterone acetate suspension Formulation 2

Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL

DRUG

Abiraterone acetate tablets

Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology, Inc. Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

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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 NCT01362764 on ClinicalTrials.gov