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

Sponsor

Novartis (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01026961

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate Blood Pressure Arrhythmias	Drug: Phenylephrine HCL Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Official Title:

A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phenylephrine HCL/Acetaminophen/Dimethindene Maleate	Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Active Comparator: Phenylephrine hydrochloride Phenylephrine hydrochloride 10mg	Drug: Phenylephrine HCL Phenylephrine HCL 10mg

Arm

Intervention/Treatment

Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

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

Active Comparator: Phenylephrine hydrochloride

Phenylephrine hydrochloride 10mg

Drug: Phenylephrine HCL

Phenylephrine HCL 10mg

Outcome Measures

Primary Outcome Measures

To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs [15 days]

Secondary Outcome Measures

Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing [15 days]
To report and evaluate adverse events [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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