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A Study Of Three PF-05190457 Formulations In Healthy Volunteers

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NCT01522807

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and females of non-childbearing potential between ages of 21 and 55
years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.

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.

NCT01522807
Pfizer
Completed
A Study Of Three PF-05190457 Formulations In Healthy Volunteers

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[email protected]

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A Study Of Three PF-05190457 Formulations In Healthy Volunteers
A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
  • Experimental: 100 mg PF-05190457
    Three fasted treatments and fed with the short-duration osmotic capsule
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
  • Experimental: 100 mg PF - 05190457
    Three fasted treatments and fed with the long-duration osmotic capsule
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01522807
B3301007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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