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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.

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00862667
Pfizer
Completed
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.

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Descriptive Information
Brief Title  ICMJE A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.
Official Title  ICMJE An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Treatment A
    PF-00241939 300ug using Inhaler A
  • Drug: Treatment B
    PF-00241939 300ug using Inhaler B
  • Drug: Treatment C
    PF-00241939 300ug using Inhaler C
Study Arms  ICMJE
  • Experimental: Treatment A
    PF-00241939 300ug using Inhaler A
    Intervention: Drug: Treatment A
  • Active Comparator: Treatment B
    PF-00241939 300ug using Inhaler B
    Intervention: Drug: Treatment B
  • Active Comparator: Treatment C
    PF-00241939 300ug using Inhaler C
    Intervention: Drug: Treatment C
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2009)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862667
Other Study ID Numbers  ICMJE B0871002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]

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