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| Name | Class |
|---|---|
| Anapharm | INDUSTRY |
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To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline by Par Pharmaceutical Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA (reference) administered as a 1 x 100 mg capsule under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions |
|
| B | Active Comparator | Subjects received the reference product, Monodox (Oclassen) under fed conditions |
|
| C | Experimental | Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline monohydrate | Drug | Capsules, 100 mg, fed |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Rate and extent of absorption | 72 hours |
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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 | G1V 2K8 | 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 |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Monodox | Drug | Capsules, 100 mg, fed |
|
|
| Doxycycline Monohydrate | Drug | Capsules, 100 mg, fasting |
|
|
| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |