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Relative Bioavailability For Palbociclib Formulations

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 .

NCT02083640
Pfizer
Completed
Relative Bioavailability For Palbociclib Formulations

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Relative Bioavailability For Palbociclib Formulations
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Palbociclib Formulation Reference
    125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.
  • Drug: Palbociclib Formulation Test
    125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1
  • Drug: Palbociclib Formulation Test
    125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2
  • Treatment A (Reference)
    Intervention: Drug: Palbociclib Formulation Reference
  • Treatment B (Test)
    Intervention: Drug: Palbociclib Formulation Test
  • Treatment C (Test)
    Intervention: Drug: Palbociclib Formulation Test
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2014
May 2014   (Final data collection date for primary outcome measure)

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 .
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02083640
A5481040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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