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The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed conditions.
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in fed Normal,Healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine Tablets, 5 mg | Experimental | Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories |
|
| Clarinex | Active Comparator | Clarinex® 5 mg Tablets of Schering-Plough |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine | Drug | Desloratadine Tablets, 5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability is based on Cmax and AUC parameters | 4 months |
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Inclusion Criteria:
A no answer to any of the above questions indicates that the individual is ineligible for enrollment
Exclusion Criteria:
Does the individual have a history of allergy or hypersensitivity to desloratadine?
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| Name | Affiliation | Role |
|---|---|---|
| Antonio R. Pizarro, M.D., | SFBC Ft. Myers, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SFBC, Ft. Myers, Inc., | Fort Myers | Florida | 33901 | United States |
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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 |
|---|---|
| C121345 | desloratadine |
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| 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 |