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The purpose of this study is to
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA in healthy, adult, human subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexofenadine HCl + Pseudoephedrine HCl | Experimental | Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories |
|
| Allegra-D 24 hour ER Tablets | Active Comparator | Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine HCl + Pseudoephedrine HCl | Drug | Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax and AUC parameters | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study, if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Dharmesh Domadia | Veeda Clinical Research Pvt. Ltd., | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veeda Clinical Research Pvt. Ltd., | Ahmedabad | Gujarat | 380015 | India |
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|
| ID | Term |
|---|---|
| C093230 | fexofenadine |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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