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

NCT02761980 ↗

Phase 3 Completed 290 enrolled Pfizer

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2016-12-06
Primary completion: 2017-12-06
Completion: 2017-12-06

Publications

Smith W, Leyva R, Kellstein D, Arthur E, Cruz-Rivera M. Efficacy of a Fixed-Dose Combination of Ibuprofen and Acetaminophen Compared With Individual Monocomponents in Adult Male Subjects With Endotoxin-Induced Fever: A Randomized Controlled Trial. Clin Ther. 2021 Jul;43(7):1213-1227. doi: 10.1016/j.clinthera.2021.05.004. Epub 2021 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	500 mg	Oral
Comparator	Ibuprofen	Small molecule	250 mg	Oral

Indications

No indication recorded.