Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

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

Details

• Lead Sponsor: PLx Pharma
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Naproxen

Criteria

Inclusion Criteria (Selected)

• Male and female healthy adult subjects

Exclusion Criteria (Selected)

• Subject has protocol specified significant medical history.

• Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.

• Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.