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

NCT01026961 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-03-03

No results posted yet for this study

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

Interventions

DRUG

Phenylephrine HCL

Phenylephrine HCL 10mg

DRUG

Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Biociências S.A · Novartis

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026961 on ClinicalTrials.gov