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

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Status and phase: Withdrawn; Phase 2; Phase 1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