A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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 and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Palbociclib

Criteria

Inclusion Criteria:

• 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 Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

• Any condition possibly affecting drug absorption