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Label indication CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) ( 1.1 ) • Rheumatoid Arthritis (RA) ( 1.2 ) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) • Ankylosing Spondylitis (AS) ( 1.4 ) • Acute Pain (AP) ( 1.5 ) • Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical… FDA label
Also known as Celebrex capsule
Celebrex · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Celebrex capsule | ACTIVE_COMPARATOR | Commercial capsule |
| D1 | EXPERIMENTAL | Test formulation D1 |
| D2 | EXPERIMENTAL | Test formulation D2 |
| D3 | EXPERIMENTAL | Test formulation D3 |
| Name | Type | Description |
|---|---|---|
| Celebrex capsule | DRUG | Single dose 200 mg commercial Celebrex capsule |
| Test formulation D1 | DRUG | Single dose 150 mg celecoxib as formulation D1 |
| Test formulation D2 | DRUG | Single dose 150 mg celecoxib as formulation D2 |
| Test formulation D3 | DRUG | Single dose 150 mg celecoxib as formulation D3 |
Inclusion Criteria: * Healthy male or female volunteers * Body weight BMI 17.5-30.5 Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease * Positive ...