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To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) |
|
| 2 | Experimental | Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) |
|
| 3 | Active Comparator | Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) | Drug |
| ||
| Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 54 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Morelli, M.D. | Early Clinical Research | Principal Investigator |
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| Drug |
|
| Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) | Drug |
|
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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