Status:
COMPLETED
A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-47 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00905814
Start Date
July 1 2009
End Date
September 1 2009
Last Update
November 16 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Singapore, Singapore, 188770