A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Bioequivalence Study To Compare The Plasma Pharmacokinetics Of Five 1-mg And One 5-mg AG-013736 Tablets In Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AG-013736
* Drug: AG-103736


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). Active smokers or users of tobacco containing products and other drugs Pregnant or nursing females; 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1 (BABA)<br>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<br>* single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)<br>* Other names: axitinib;|
| Other: Sequence 2 (ABAB)<br>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<br>* single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)<br>* Other names: axitinib;|

What is the study measuring?
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Primary Outcome Measures

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

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

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