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| Name | Class |
|---|---|
| Anapharm | INDUSTRY |
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The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.
To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received the Par formulated product |
|
| B | Active Comparator | Subjects received the Oclassen Pharmaceuticals formulated product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline monohydrate | Drug | Tablets, 100 mg, single, oral dose |
| |
| 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 |
|---|---|---|
| Eric Masson, Pharm.D. | Anapharm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anapharm Inc. | Sainte-Foy | Quebec | Canada |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| doxycycline monohydrate |
| Drug |
Capsule, 100 mg, single, oral dose |
|
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |