ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers (B0871003)

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: NCT00867282
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Pharmacokinetics Drug: Treatment A Drug: Treatment B Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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.
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Treatment A Drug: Treatment A
PF-00241939 750ug using inhaler A
Active Comparator: Treatment B Drug: Treatment B
PF-00241939 750ug using inhaler B



Primary Outcome Measures :
  1. Plasma pharmacokinetic parameters: AUClast & Cmax. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½. [ Time Frame: 48 hours ]


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.

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): NCT00867282


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00867282     History of Changes
Other Study ID Numbers: B0871003
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009