Status:
COMPLETED
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies ...
Eligibility Criteria
Inclusion
- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Any condition possibly affecting drug absorption
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01906125
Start Date
September 1 2013
End Date
January 1 2014
Last Update
January 20 2014
Active Locations (1)
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1
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212