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

Last updated on March 14, 2019

Study Location
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of
age, inclusive.

2. The subject must have a normal, stable body temperature at Screening and on Day 0.

3. Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs)
at Screening.

4. The subject has demonstrably adequate veins, by visual inspection, for IV catheter

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Evidence or history of clinically significant laboratory abnormality, hematological,
renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time
of dosing) within the last 5 years that may increase the risk associated with study

2. Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy,
esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected
obstructive disease, previous gastrointestinal surgery, felinization of the
esophagus, hypomotility of the gastrointestinal track) that could affect the
absorption, metabolism, or excretion of the study medication or affect the results of
the ingestible thermometer.

3. Subjects at risk for excessive bleeding.

4. Subjects with a history of nasal polyps, angioedema, or significant or actively
treated bronchospastic disease.

5. Screening supine blood pressure ?90 or ?140 mm Hg (systolic) or ?50 or ?90 mm Hg
(diastolic), following at least 5 minutes of supine rest.

6. Screening supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec
at Screening and on Day 1 prior to RSE administration.

7. The subject has a history of recurrent or acute or chronic infections of any type or
any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary
tract infection, respiratory tract or dental (abscess) infection, etc., or those with
a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C
antibody, and/or Human immunodeficiency virus (HIV) test at Screening.

8. Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever)
within 2 weeks prior to the first administration of study treatments.

9. Subjects with a reduction in heart rate to ?50 beats per minute or deemed to be at
high risk of syncope and/or hypotension per the clinical judgment of the investigator
following a carotid sinus massage procedure.

Trial Details
The form in which the study drug will be delivered to the patient's body.
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
The time commitment for participation in the study.
Follow up: Estimated 28 days
Screening: Estimated 14 days
Treatment: Estimated 2 days
Site Visits
Follow up: visits
Screening: 1 visits
Treatment: 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Electrocardiogram (ECG)
Physical examination
Urine test
Vital signs and measurements
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic (Fever Reduction) Effects in Healthy Male Volunteers


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