A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/1/2014 |
| Start Date: | September 2013 |
| End Date: | December 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Open-Label 3 Sequence 3 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 1/2 And Phase 3 Formulation To Palbociclib ICH Formulation Under Fasted Conditions
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.
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.
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
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