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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 fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received kali product under fasting conditions |
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| B | Active Comparator | Subjects received Searle product under fasting conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Capsules, single-dose, fasting |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence | To conclude bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Sicard, M.D | Algotithme Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma | Laval | Quebec | H7V 4B4 | Canada |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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, fasting |
|
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |