567
Participants
Start Date
March 26, 2025
Primary Completion Date
August 26, 2025
Study Completion Date
August 26, 2025
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.
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.
Eurofarma Laboratórios S.A, São Paulo
Clinica de Alergia Martti Antila, Sorocaba
Lead Sponsor
Eurofarma Laboratorios S.A.
INDUSTRY