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A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857571
Recruitment Status : Terminated
First Posted : March 6, 2009
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Condition or disease Intervention/treatment Phase
Healthy Drug: 150 mg Suspension Drug: 30 mg Suspension Drug: 400 mg Suspension Drug: 5 mg Suspension Drug: 750 mg Suspension Drug: 150 mg Tablet Drug: 30 mg Tablet Drug: 400 mg Tablet Drug: 5 mg Tablet Drug: 750 mg Tablet Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.
Study Start Date : April 2009
Primary Completion Date : May 2009
Study Completion Date : May 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Suspension
PF-02413873 suspension
Drug: 150 mg Suspension
Single oral dose of 150 mg of PF-02413873 suspension
Drug: 30 mg Suspension
Single oral dose of 30 mg of PF-02413873 suspension
Drug: 400 mg Suspension
Single oral dose of 400 mg of PF-02413873 suspension
Drug: 5 mg Suspension
Single oral dose of 5 mg of PF-02413873 suspension
Drug: 750 mg Suspension
Single oral dose of 750 mg of PF-02413873 suspension
Experimental: Tablet
PF-02413873 Phase 2 Tablets
Drug: 150 mg Tablet
Single oral dose of 150 mg of PF-02413873 tablets
Drug: 30 mg Tablet
Single oral dose of 30 mg of PF-02413873 tablets
Drug: 400 mg Tablet
Single oral dose of 400 mg of PF-02413873 tablets
Drug: 5 mg Tablet
Single oral dose of 5 mg of PF-02413873 tablets
Drug: 750 mg Tablet
Single oral dose of 750 mg of PF-02413873 tablets


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ]

Secondary Outcome Measures :
  1. Tmax, Tlag, AUClast, AUCt, t½, Frel. [ Time Frame: June-July 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers.
  • Female volunteers have to be of non-childbearing potential

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857571


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00857571     History of Changes
Other Study ID Numbers: B0461003
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Pfizer:
Dose Response Bioavailability Study