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A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181700
First Posted: August 13, 2010
Last Update Posted: January 24, 2011
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 is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

Condition Intervention Phase
Pharmacokinetics Drug: Treatment A Drug: Treatment B Drug: Treatment C Drug: Treatment D Drug: Treatment E Drug: Treatment F Drug: Treatment G Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma pharmacokinetic parameters: AUClast and Cmax. [ Time Frame: 36 hours ]

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameters: AUC24, AUCinf, Tmax and half-life. [ Time Frame: 36 hours ]

Enrollment: 42
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Treatment A
PF-00241939 300 ug using inhaler A
Experimental: Treatment B Drug: Treatment B
PF-00241939 300 ug using inhaler A
Experimental: Treatment C Drug: Treatment C
PF-00241939 300 ug using inhaler A
Active Comparator: Treatment D Drug: Treatment D
PF-00241939 300 ug using inhaler B
Active Comparator: Treatment E Drug: Treatment E
PF-00241939 300 ug using inhaler B
Active Comparator: Treatment F Drug: Treatment F
PF-00241939 300 ug using inhaler B
Active Comparator: Treatment G Drug: Treatment G
PF-00241939 300 ug 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:   21 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.
  • 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).
  • Pregnant or nursing females.
  • 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): NCT01181700


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: NCT01181700     History of Changes
Other Study ID Numbers: B0871015
First Submitted: August 11, 2010
First Posted: August 13, 2010
Last Update Posted: January 24, 2011
Last Verified: January 2011