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A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers. (B0871002)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862667
First Posted: March 17, 2009
Last Update Posted: June 24, 2009
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 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Condition Intervention Phase
Healthy Drug: Treatment A Drug: Treatment B Drug: Treatment C 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 & Cmax. [ Time Frame: 48 hours ]

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

Enrollment: 36
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
PF-00241939 300ug using Inhaler A
Drug: Treatment A
PF-00241939 300ug using Inhaler A
Active Comparator: Treatment B
PF-00241939 300ug using Inhaler B
Drug: Treatment B
PF-00241939 300ug using Inhaler B
Active Comparator: Treatment C
PF-00241939 300ug using Inhaler C
Drug: Treatment C
PF-00241939 300ug using Inhaler C

  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).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • 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): NCT00862667


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: NCT00862667     History of Changes
Other Study ID Numbers: B0871002
First Submitted: February 19, 2009
First Posted: March 17, 2009
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by Pfizer:
Pharmacokinetics