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Sponsored by: |
Pozen |
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Information provided by: | Pozen |
ClinicalTrials.gov Identifier: | NCT00665743 |
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.
Condition | Intervention | Phase |
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Arthritis |
Drug: PN400 Drug: naproxen |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
PN400 (naproxen/esomeprazole)
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Drug: PN400
naproxen 500 mg /esomeprazole 20 mg
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B: Active Comparator
naproxen 500 mg
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Drug: naproxen
naproxen 500 mg tablet
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C: Active Comparator
naproxen 500 mg
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Drug: naproxen
naproxen 500 mg
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pozen ( David Taylor ) |
Study ID Numbers: | PN400-102 |
Study First Received: | April 23, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00665743 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Naproxen Joint Diseases Cyclooxygenase Inhibitors Omeprazole Healthy Musculoskeletal Diseases |
Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Gout Suppressants Pharmacologic Actions Musculoskeletal Diseases |
Analgesics, Non-Narcotic Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |