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A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00928278
First received: June 24, 2009
Last updated: December 18, 2009
Last verified: December 2009
History of Changes

June 24, 2009
December 18, 2009
July 2009
October 2009   (final data collection date for primary outcome measure)
Plasma pharmacokinetic parameters: AUClast and Cmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928278 on ClinicalTrials.gov Archive Site
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Treatment A
    Inhaled, 300/150, single dose
  • Drug: Treatment B
    Inhaled, 300/150, single dose
  • Drug: Treatment C
    Inhaled, 300/150, single dose + oral activated charcoal block
  • Drug: Treatment D
    Inhaled, 300/150, single dose + oral activated charcoal block
  • Experimental: Treatment A - PF-04764793
    PF-04764793 using inhaler A
    Intervention: Drug: Treatment A
  • Active Comparator: Treatment B - PF-04764793
    PF-04764793 using inhaler B
    Intervention: Drug: Treatment B
  • Experimental: Treatment C - PF-04764793
    PF-04764793 using inhaler A
    Intervention: Drug: Treatment C
  • Active Comparator: Treatment D - PF-04764793
    PF-04764793 using inhaler B
    Intervention: Drug: Treatment D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2009
October 2009   (final data collection date for primary outcome measure)

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/m^2; 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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00928278
B1691001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP