Relative Bioavailability For Palbociclib Formulations
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/5/2014 |
Start Date: | March 2014 |
End Date: | May 2014 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 1, Open-Label, 6 Sequence, 3 Period, Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Relative Bioavailability Of 3 Palbociclib Formulations
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule
formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin
capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib
hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single
125 mg oral doses under fed conditions in healthy volunteers.
formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin
capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib
hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single
125 mg oral doses under fed conditions in healthy volunteers.
Inclusion Criteria:
- Healthy male subjects and/or female subjects with no physical possibility of getting
pregnant.
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of
the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures.
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 (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) preceding the first dose of study medication.
- Pregnant females; breastfeeding females; females with physical possibility of getting
pregnant .
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