A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers
Condition: Fever
MeSH terms: Fever
Intervention: Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; Acetaminophen 500 mg; Placebo
Intervention description: Ibuprofen 250 mg / Acetaminophen 500 mg; Ibuprofen 250 mg; 1 APAP 500 mg caplet; Placebo tablet
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 290.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ibuprofen; acetaminophen; induced fever; fever

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.
    

Eligibility 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.