A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AG-103736; Drug: AG-013736

• Registration Number: NCT00905814
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Study Start: 2009-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-13
• Last Update Posted: 2009-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2 (ABAB)	AG-103736	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
Sequence 1 (BABA)	AG-013736	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

Primary Outcome Measures

Name	Time	Method
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.	3 days per period

Secondary Outcome Measures

Name	Time	Method
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.	3 days per period

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore