Lead Sponsor

Iroko Pharmaceuticals, LLC

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

No

•Primary diagnosis of Functional Class I-III OA of the hip or knee
•Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain
•Discontinued all analgesic therapy at Screening
•For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

•History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
•Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
•Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
•Significant difficulties swallowing capsules or unable to tolerate oral medication
•Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening