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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.
To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (BABA) | Experimental | 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) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-013736 | Drug | single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| AG-013736 | Drug | single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions) |
|
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |