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

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.

Timeline

Start

2013-09

Primary completion

2014-01

Completion

2014-01

Drugs

Indications

No indication recorded.