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

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Novartis

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Arrhythmias
Heart Rate
Blood Pressure

Treatments

Drug: Phenylephrine HCL
Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026961
381-A-101

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 50 years old

Volunteers

No 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

Trial design

0 participants in 2 patient groups

Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Experimental group
Description:
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Treatment:
Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine hydrochloride
Active Comparator group
Description:
Phenylephrine hydrochloride 10mg
Treatment:
Drug: Phenylephrine HCL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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