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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Acetaminophen; Dimethindene; Maleic acid; Oxymetazoline; Phenylephrine

Criteria

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