Overview

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

Status:
Completed
Trial end date:
2017-12-06
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Treatments:
Acetaminophen
Antipyretics
Ibuprofen
Criteria
Inclusion Criteria:

1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of
age, inclusive. Healthy is defined as no clinically relevant abnormalities identified
by a detailed medical history, full physical examination, including blood pressure and
pulse rate measurement, 12 lead ECG and clinical laboratory tests.

2. The subject must have a normal, stable body temperature at Screening and on Day 0. If
the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional
oral temperature readings will be obtained within a 30 minute period. These 3
consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest
value within 0.4°F of the lowest temperature value.

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
insertion.

Exclusion Criteria:

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
participation.

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. If blood pressure (BP) is
≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be
repeated two more times and the average of the three consecutive BP values should be
used to determine the subject's eligibility.

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. If QTc exceeds 450 msec, or QRS
exceeds 120 msec, the ECG should be repeated two more times and the average of the
three consecutive QTc or QRS values should be used to determine the subject's
eligibility.

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. Also excluded
are subjects with frequent (more than 3 outbreaks per year), recurrent oral or genital
herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator
to have the potential for exacerbation by participation in the study.

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.