Ibuprofen Versus Placebo For Muscle Soreness

A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS

The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.

This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.

The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.

Subjects must meet the following criteria to be included in the study:

1. Male or female subjects aged 18-55 years;

2. In good general health;

3. Non-pregnant, non-lactating female subjects must be:

   1. physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
   2. practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization.

4. History of experiencing muscle pain/soreness after moderately strenuous exercise;

Subjects are excluded from the study if any of the following criteria apply:

1. Currently participating in an exercise regimen.
2. Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
3. History of rhabdomyolysis;
4. Have participated in an investigational study within the past 30 days of screening;
5. Are an employee or relative of an employee of the study site (directly involved with the study).