A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00905814
First received: May 20, 2009
Last updated: November 13, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: AG-013736
Drug: AG-103736
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I Bioequivalence Study To Compare The Plasma Pharmacokinetics Of Five 1-mg And One 5-mg AG-013736 Tablets In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To establish bioequivalence of five 1 mg film coated immediate release (FCIR) tablets of AG-013736 to one 5 mg FCIR tablet of AG-013736. [ Time Frame: 3 days per period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of single dose AG-013736 when administered as five 1 mg FCIR tablets and one 5 mg FCIR tablet. [ Time Frame: 3 days per period ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

  Eligibility

Ages Eligible for Study:   21 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905814

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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00905814     History of Changes
Other Study ID Numbers: A4061052
Study First Received: May 20, 2009
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence

ClinicalTrials.gov processed this record on April 17, 2014