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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00618163 |
The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Condition | Intervention |
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Inflammation |
Drug: Meloxicam |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fasting Conditions |
Enrollment: | 47 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 |
Principal Investigator: | Soran Hong, MD | Novum Pharmaceutical Research Services |
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | MELO-T15-PVFS-1 |
Study First Received: | January 15, 2008 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00618163 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-inflammatory |
Anti-Inflammatory Agents Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Meloxicam Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Antirheumatic Agents Inflammation |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Meloxicam Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Inflammation Pathologic Processes |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |