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Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00499538
First received: July 9, 2007
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.


Condition Intervention Phase
Healthy
 Drug: SKI-606
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single Dose Bioavailability Study of 3 New Formulations of SKI-606 (500 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

Resource links provided by NLM:

Drug Information available for: Bosutinib
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for SKI-606 to support formulation development.

Estimated Enrollment: 40
Study Start Date: July 2007
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Criteria:

  • Healthy male and female aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499538

Locations
United States, Texas
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00499538     History of Changes
Other Study ID Numbers: 3160A4-1109
Study First Received: July 9, 2007
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects

ClinicalTrials.gov processed this record on May 19, 2013