Phase II Study of AP0302 5% Versus a Vehicle Comparator

Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Inclusion Criteria:

• no clinically significant medical conditions
• BMI between 18-30
• negative drug, alcohol, pregnancy screens
• other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• no upper extremity workout in last 6 months
• no job requiring heavy lifting
• history of muscle disorders
• allergy or intolerance to study drug
• history of recent pain medication use
• other protocol-defined exclusion criteria may apply