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A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043276
First Posted: January 6, 2010
Last Update Posted: April 27, 2010
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.
Information provided by:
Pfizer
  Purpose
The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers

Condition Intervention Phase
Asthma Drug: Treatment A Drug: Treatment B Drug: Treatment C Drug: Treatment D Drug: Treatment E Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • plasma pharmacokinetics AUClast and Cmax [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • plasma pharmacokinetics, AUCinf and Tmax [ Time Frame: Day 1 ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Treatment A
PF-00258210 220 µg using inhaler A
Experimental: Treatment B Drug: Treatment B
PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A
Experimental: Treatment C Drug: Treatment C
PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A
Experimental: Treatment D Drug: Treatment D
PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A
Experimental: Treatment E Drug: Treatment E
PF-00258210 220 µg using inhaler B

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

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

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)
  • A positive urine drug screen
  • Pregnant or nursing females
  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): NCT01043276


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: NCT01043276     History of Changes
Other Study ID Numbers: B0751001
First Submitted: December 7, 2009
First Posted: January 6, 2010
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Pfizer:
Healthy