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

Study Overview
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Brief Summary
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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
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To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

Official Title
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A Phase 1 Bioequivalence Study To Compare The Plasma Pharmacokinetics Of AG-013736 Polymorph Form IV Versus Market-Image Polymorph Form XLI Tablets In Healthy Volunteers Under Fed Conditions

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: AG-013736
* Drug: AG-013736


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 (BABA)<br>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 | Drug: AG-013736<br>* single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)<br>|
| Experimental: Sequence 2 (ABAB)<br>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 | Drug: AG-013736<br>* single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence Pharmacokinetics