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| ID | Type | Description | Link |
|---|---|---|---|
| CL2010-18 | Other Identifier | Protocol Number | |
| P08340 | Other Identifier | Merck |
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This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine HCl Extended Release - Fasted | Experimental | Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods |
|
| Phenylephrine HCl Extended Release - Fed | Experimental | Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods |
|
| Phenylephrine HCl Immediate Release - Fasted | Active Comparator | Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered under fasted conditions on Day 1 in one of four study periods |
|
| Phenylephrine HCl Immediate Release - Fed | Active Comparator | Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine HCl Extended Release | Drug | One phenylephrine HCl 30 mg extended release tablet orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of phenylephrine | 0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) | |
| Time to Cmax (Tmax) of phenylephrine | 0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) | |
| Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC[0-t]) | 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) | |
| Area under the concentration versus time curve from time 0 to infinity (AUC[0-∞]) | 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) | |
| Terminal rate constant (λz) | 0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) | |
| Terminal elimination half-life (t1/2) | 0 hours to t1/2 of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Phenylephrine HCl Immediate Release | Drug | One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses |
|
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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