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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
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The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
To compare the relative Bioavailability of Metronidazole 375 mg Capsules with that of Flagyl 375 mg Capsules in healthy, adult subjects under fed conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received kali product under fed conditions |
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| B | Active Comparator | Subjects received Searle product under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Capsules, single-dose, fed |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence | To conclude bioequivalence the exponential of the difference between the test and reference product for Cmax, AUCt and AUC∞ should be between 80 and 125%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Aumais, M.D | Algorithme Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc | Montreal | Quebec | H4N 2Y8 | 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 |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Flagyl | Drug | Capsules, single-dose, fed |
|
|
| 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 |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |