Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects
Sponsor
Puma Biotechnology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00498745
Collaborator
(none)
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1
2
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects
Study Start Date
:
Jul 1, 2007
Actual Study Completion Date
:
Sep 1, 2007
Outcome Measures
Primary Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria:
-
Healthy male and female subjects aged 18 to 50 years.
-
Women of nonchildbearing potential (WONCBP)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Antonio | Texas | United States | 78217 |
Sponsors and Collaborators
- Puma Biotechnology, Inc.
Investigators
- Study Director: Puma, Biotechnology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00498745
Other Study ID Numbers:
- 3144A1-1109
First Posted:
Jul 10, 2007
Last Update Posted:
May 14, 2012
Last Verified:
May 1, 2012