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Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

Last updated on October 4, 2018

FOR MORE INFORMATION
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 and/or female (non childbearing potential) subjects between the ages of
18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women
must be of non childbearing potential as defined in Lifestyle Guidelines.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- An informed consent document signed and dated by the subject or a legally acceptable
representative.

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 (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.

- Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a
single measurement [confirmed by a single repeat, if necessary] following at least 5
minutes of rest.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

NCT01388829
Pfizer
Completed
Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

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Similar Trials

Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532
A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532
This study is designed to compare the pharmacokinetics of two different lots of tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Treatment A
    150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot
  • Drug: Treatment B
    150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot
Experimental: formulation comparison
formulation comparison
Interventions:
  • Drug: Treatment A
  • Drug: Treatment B
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
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
 
 
NCT01388829
B2611015
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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