A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

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NCT00905814

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Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-47 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 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- An informed consent document signed and dated by the subject or a legally acceptable representative.

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


- Evidence of significant disease of the blood, kidney, endocrine system, lungs,
gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug
allergies, but excluding season allergies).


- Active smokers or users of tobacco containing products and other drugs


- Pregnant or nursing females; females of childbearing potential including those with
tubal ligation.

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers
Official Title  ICMJE A Phase I Bioequivalence Study To Compare The Plasma Pharmacokinetics Of Five 1-mg And One 5-mg AG-013736 Tablets In Healthy Volunteers
Brief Summary The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: AG-013736
    single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
    Other Name: axitinib
  • Drug: AG-103736
    single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
    Other Name: axitinib
Study Arms  ICMJE
  • Sequence 1 (BABA)
    Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: B -> A -> B -> A
    Intervention: Drug: AG-013736
  • Sequence 2 (ABAB)
    Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: A -> B -> A -> B
    Intervention: Drug: AG-103736
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: May 20, 2009)		60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 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 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

  • Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies).
  • Active smokers or users of tobacco containing products and other drugs
  • Pregnant or nursing females; females of childbearing potential including those with tubal ligation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 47 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 NCT00905814
Other Study ID Numbers  ICMJE A4061052
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 November 2009

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