A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

Back to Search
Print
Bookmark Trial

NCT01043276

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 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, inclusive

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


- Pregnant or nursing females

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

AsthmaPF-04191834 Single Dose Bronchodilatory Study In Asthma. NCT00723021
  1. Baltimore, Maryland
  2. North Dartmouth, Massachusetts
  3. Kalamazoo, Michigan
  4. Omaha, Nebraska
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AsthmaA Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355 NCT01043276
  1. Singapore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AsthmaStudy Evaluating Etanercept in Moderate to Severe Asthma NCT00141791
  1. Birmingham, Alabama
  2. Denver, Colorado
  3. Sarasota, Florida
  4. Tallahassee, Florida
  5. Valrico, Florida
  6. Covington, Louisiana
  7. Wheaton, Maryland
  8. Boston, Massachusetts
  9. Rockville Center, New York
  10. Winston-Salem, North Carolina
  11. Portland, Oregon
  12. Richmond, Virginia
  13. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AsthmaA Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics NCT00150397
  1. Encinitas, California
  2. Riverside, California
  3. DeLand, Florida
  4. Atlanta, Georgia
  5. Normal, Illinois
  6. Madisonville, Kentucky
  7. North Dartmouth, Massachusetts
  8. Springfield, Massachusetts
  9. Minneapolis, Minnesota
  10. Skillman, New Jersey
  11. Cincinnati, Ohio
  12. Lincoln, Rhode Island
  13. Kingsport, Tennessee
  14. Nashville, Tennessee
  15. Dallas, Texas
  16. Madison, Wisconsin
  17. Barrio Aranjuez, San Jose
  18. San Jose,
  19. Mumbai, Maharashtra
  20. Chennai, Tamil Nadu
  21. Vellore, Tamilnadu
  22. Noida, Uttar Pradesh
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355
Official Title  ICMJE A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination
Brief Summary The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers
Detailed Description Not 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 Asthma
Intervention  ICMJE
  • Drug: Treatment A
    PF-00258210 220 µg using inhaler A
  • Drug: Treatment B
    PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A
  • Drug: Treatment C
    PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A
  • Drug: Treatment D
    PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A
  • Drug: Treatment E
    PF-00258210 220 µg using inhaler B
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: Treatment A
  • Experimental: Treatment B
    Intervention: Drug: Treatment B
  • Experimental: Treatment C
    Intervention: Drug: Treatment C
  • Experimental: Treatment D
    Intervention: Drug: Treatment D
  • Experimental: Treatment E
    Intervention: Drug: Treatment E
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: January 5, 2010)		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (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, inclusive

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
  • Pregnant or nursing females
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 NCT01043276
Other Study ID Numbers  ICMJE B0751001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2010

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