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:
Participant gender:
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.