Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00498745
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Study Completion: 2007-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.