NCT01026961

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Rate
• Blood Pressure
• Arrhythmias

Interventions

Type	Name	Description
DRUG	Phenylephrine HCL	Phenylephrine HCL 10mg
DRUG	Phenylephrine HCL/Acetaminophen/Dimethindene Maleate	Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• First posted: 2009-12-07
• Last updated: 2016-03-03

Locations

1 site across 1 country: Brazil