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| Name | Class |
|---|---|
| Phoenix International Life Sciences, Inc. | INDUSTRY |
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To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received the Par formulated product under fasting conditions |
|
| B | Experimental | Subjects received the Par formulated product under fed conditions |
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| C | Active Comparator | Subjects received the Bristol-Myers Squibb formulated product under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone HCl | Drug | Tablets, 30 mg, single-dose, fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate and extent of absorption | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Surfaty, MD | Phoenix International Life Sciences, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix International Life Sciences inc | Saint-Laurent | Quebec | H4R 2N6 | Canada |
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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 |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Buspirone HCl | Drug | Tablets, 30 mg, single-dose, fed conditions |
|
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| Buspar | Drug | Tablets, 30 mg, single-dose, 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 |
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |