A Study of Ibuprofen (IBU) 250mg/Acetaminophen (APAP) 500mg In The Treatment Of Post-Surgical Dental Pain

• Drug: FDC IBU/APAP 250 mg/500 mg
  
  FDC IBU/APAP 250 mg/500 mg
• Drug: Placebo
  
  Placebo

• Active Comparator: Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg
  
  FDC IBU/APAP 250 mg/500 mg
  Intervention: Drug: FDC IBU/APAP 250 mg/500 mg
• Placebo Comparator: Placebo
  
  Placebo
  Intervention: Drug: Placebo

Inclusion Criteria

1. Males and females 18 years to 40 years of age (inclusive).
2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
4. In general good health and have no contraindications to the study or rescue medication.

Exclusion Criteria

1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening of the following medical conditions/disorders:

   • Gastrointestinal ulcer or gastrointestinal bleeding;
   • Paralytic ileus or other gastrointestinal obstructive disorders;
   • Bleeding disorder.
2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.

3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.