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A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01366287
First received: January 4, 2011
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: PF-03882845
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit. [ Time Frame: predose and post each dose (24, 48 and 96 hour timepoints) ] [ Designated as safety issue: No ]
    Post dose is measured at 24, 48 and 96 hours after dose.

  • Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suspension/fasted Drug: PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Experimental: Tablet/fasted Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Experimental: Tablet/fed Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Serum potassium >5 mEq/L at screening.
  • Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366287

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01366287     History of Changes
Other Study ID Numbers: B0171006
Study First Received: January 4, 2011
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative bioavailability
food effect
tablet
suspension
 single dose
crossover
healthy subjects

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013