NCT02761980

A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers

A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets In Healthy Male Volunteers With Fever Induced By An Endotoxin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	Ibuprofen 250 mg / Acetaminophen 500 mg	Ibuprofen 250 mg / Acetaminophen 500 mg
DRUG	Ibuprofen 250 mg	Ibuprofen 250 mg
DRUG	Acetaminophen 500 mg	1 APAP 500 mg caplet
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2016-12-06
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2016-05-04
• Last updated: 2018-12-07
• Results posted: 2018-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study