Salt Lake City,
This is a dental pain study evaluating the efficacy and safety of a single dose of test
acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen
(IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of
three or four third molars.
1. Are 17 to 50 years of age
2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
3. Dental extraction of three or four third-molars.
4. Experience moderate to severe pain after extraction of third molars
1. Currently pregnant (or planning to be pregnant) or nursing a baby
2. Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or
the integrity of the study