Not provided
Not provided
Not provided
Not provided
Not provided
Study is no longer required by Brazil health authority.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine HCL/Acetaminophen/Dimethindene Maleate | Experimental | Phenylephrine HCL/Acetaminophen/Dimethindene Maleate |
|
| Phenylephrine hydrochloride | Active Comparator | Phenylephrine hydrochloride 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine HCL | Drug | Phenylephrine HCL 10mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing | 15 days | |
| To report and evaluate adverse events | 15 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Biociências S.A | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scentryphar Pesquisa Clinica Ltda. | Campinas | São Paulo | Brazil |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phenylephrine HCL/Acetaminophen/Dimethindene Maleate |
| Drug |
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D054160 | Systolic Murmurs |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006337 | Heart Murmurs |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D004115 | Dimethindene |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D011083 | Polycyclic Compounds |
Not provided
Not provided