Arrhythmias, Blood Pressure, Heart Rate
Conditions
Keywords
Safety, heart rate, systolic and diastolic blood pressure, arrhythmias
Brief summary
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.
Interventions
Phenylephrine HCL 10mg
DRUGPhenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy volunteers between 18 and 50 years; * Clinical examination without abnormal findings * Ability to understand the nature and purpose of the study, including the risks and adverse effects
Exclusion criteria
* Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia * History of serious adverse reactions or hypersensitivity any drug * Hypersensitivity to the drug study drugs or chemically related compounds
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing | 15 days |
| To report and evaluate adverse events | 15 days |
Countries
Brazil
Outcome results
None listed