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Sponsored by: |
Perrigo Company |
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Information provided by: | Perrigo Company |
ClinicalTrials.gov Identifier: | NCT00804401 |
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.
Condition | Intervention |
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Bioequivalency |
Drug: Naproxen Tablets, 500 mg |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions |
Enrollment: | 34 |
Study Start Date: | June 2004 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Test Product: Active Comparator | Drug: Naproxen Tablets, 500 mg |
Reference Product: Active Comparator | Drug: Naproxen Tablets, 500 mg |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Perrigo Company ( Diane Morgan ) |
Study ID Numbers: | 40061 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804401 History of Changes |
Health Authority: | Canada: Health Canada |
bioequivalency Naproxen |
Anti-Inflammatory Agents Naproxen Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Healthy Antirheumatic Agents |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |