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To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA) |
|
| 2 | Active Comparator | Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA) | Drug |
| ||
| Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueyu (Eric) Chen, M.D. | Pharma Medica Research, Inc. | Principal Investigator |
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| Drug |
|
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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