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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: palbociclib capsule: phase 1 and 2 studies

Drug: Palbociclib capsule: ICH

Drug: Palbociclib capsule: phase 3 studies

Study type

Interventional

Funder types

Industry

Identifiers

NCT01906125

A5481020

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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