A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

Inclusion Criteria:

- are male or female, 18-55 years of age

- are a sexually active female of childbearing potential willing to use a medically
acceptable form of birth control throughout the study and for 30 days following the
end of study participation

- have a history of experiencing muscle soreness after moderately strenuous exercise

- are in good general health, with a BMI less than or equal to 30, and able to perform
the exercise regimen

- are able to read, comprehend, and sign the informed consent form

- develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen
and have a baseline muscle pain/soreness with movement of greater than or equal to 5
on the NRS (numerical rating scale) and at least "moderate" on the categorical scale

Exclusion Criteria:

- regularly works out or exercises the upper extremities with weights or gym equipment
during the past 6 months

- works in an occupation that requires regular heavy lifting or involvement of the
upper extremities (eg: mover, construction workers)

- allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin
or acetaminophen

- the presence of any medical condition (eg: history of bleeding ulcers or current
peptic ulcer disease) that would preclude the subject from safely participating in
the study'

- any form of arthritis that requires prescription or over-the-counter (OTC)treatment
pregnant or lactating female

- current habituation or history of chronic use of analgesic or drugs or severe chronic
pain problems that do not respond to OTC medication and/or requires a prescription
analgesic

- currently on chronic NSAID therapy for any reason

- current or recent history of drug or alcohol abuse

- has taken an analgesic medication within 5 half lives of performing the exercise
regimen during the run-in period or completing the baseline assessment

- has donated blood within the past 30 days

- is unable to swallow whole or large tablets or capsules

- is unable/unwilling to remain at the study center for the 6 hour inpatient
observation period.

- participation in an investigational study within the past 30 days of screening

- prior participation in this trial

- site employee or close relative of a site employee directly involved in the conduct
or the study or is an employee or close relative of the study doctor.