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

NCT02761980 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2018-12-07

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-06
Primary Completion
2017-12-06
Completion
2017-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02761980 on ClinicalTrials.gov