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Study to compare the bioavailable fraction of epinastine and pseudoephedrine when administered as a fixed dose combination in tablet form (new pharmaceutical formulation), with that obtained with each of these drugs when administered separately to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinastine and Pseudoephedrine combination | Experimental |
| |
| Epinastine | Active Comparator |
| |
| Pseudoephedrine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinastine | Drug |
| ||
| Pseudoephedrine |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of the analyte in plasma | Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose | |
| Index of the absorption rate Cpmax/AUCt (Peak plasma concentration/Area under the curve from zero to 24 hours) | Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cpmax) | Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose | |
| Tmax (Time to reach Cpmax) | Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C053090 | epinastine |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
|
| Epinastine + Pseudoephedrine combination | Drug |
|
| T1/2 (Drug half-life) | Pre-dose, 15, 30, 45 minutes and 1, 2, 4, 6, 8, 12, 24 hours post-dose |
| Number of patients with adverse events | up to 15 days |
| Number of withdrawals and discontinuations due to safety reasons | up to 15 days |
| Number of patients with clinically significant changes in vital signs | Baseline, day 1, 8, 15 |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |