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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
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To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg
To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received Kali formulated products under fed conditions |
|
| B | Active Comparator | Subjects received GlaxoSmithKline's formulated products under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | ODT, 8 mg, single-dose, fed conditions |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Extend of Absorption | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Aumais | Algotithme Pharma Inc | Principal Investigator |
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| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Zofran | Drug | ODT, 8 mg, single-dose, under fed conditions |
|
|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |