Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Rate Blood Pressure Arrhythmias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Group Type EXPERIMENTAL

Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Intervention Type DRUG

Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg

Phenylephrine hydrochloride

Phenylephrine hydrochloride 10mg

Group Type ACTIVE_COMPARATOR

Phenylephrine HCL

Intervention Type DRUG

Phenylephrine HCL 10mg

Interventions

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Phenylephrine HCL

Phenylephrine HCL 10mg

Intervention Type DRUG

Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No