A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AG-013736

• Registration Number: NCT01020136
• Lead Sponsor: Pfizer

Brief Summary

The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.

Detailed Description

To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

Study Timeline

• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Study Start: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-21
• Last Update Posted: 2010-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)
• Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
• Pregnant or nursing females and females of childbearing potential including those with tubal ligation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1 (BABA)	AG-013736	Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -\> A -\> B -\> A
Sequence 2 (ABAB)	AG-013736	Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -\> B-\> A -\> B

Primary Outcome Measures

Name	Time	Method
To establish the bioequivalence of test 5 mg market-image tablets of AG-013736 polymorph Form XLI to reference 5 mg tablets of AG- 013736 polymorph Form IV under fed conditions.	3 days per period

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of single dose AG-013736 when administered as polymorph Forms XLI and IV in healthy volunteer	3 days per period

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore