Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment

PHASE3CompletedINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

March 26, 2025

Primary Completion Date

August 26, 2025

Study Completion Date

August 26, 2025

Conditions
ColdFlu Symptom
Interventions
DRUG

Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

DRUG

Placebo

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

Trial Locations (2)

06696-000

Eurofarma Laboratórios S.A, São Paulo

Unknown

Clinica de Alergia Martti Antila, Sorocaba

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY

NCT05118672 - Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment | Biotech Hunter | Biotech Hunter