Phase II Study of AP0302 5% Versus a Vehicle Comparator

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aponia Laboratories, Inc.
• Treatments: Ibuprofen

Criteria

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