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Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geodon fed | Active Comparator | Commercial Geodon (ziprasidone) capsules given with food |
|
| B16 Fasted | Experimental | Experimental reduced food effect formulation given without food |
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| B16 Fed | Experimental | Experimental reduced food effect formulation given with food |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone | Drug | 40 mg capsule, single dose x 3 |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events reported, laboratory test results, vital signs observed with each study treatment | 2 months |
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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 | New Haven | Connecticut | 06511-5473 | United States |
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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 |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| B16 Fasted | Drug | 40 mg tablet, single dose X 3 |
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| B16 Fed | Drug | 40 mg tablet, single dose X 3 |
|