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Sponsors and Collaborators: |
Pozen AstraZeneca |
---|---|
Information provided by: | Pozen |
ClinicalTrials.gov Identifier: | NCT00729495 |
Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteer |
Drug: celecoxib |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Single Group Assignment, Bio-availability Study |
Official Title: | Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers |
Estimated Enrollment: | 80 |
Study Start Date: | July 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
marketed celecoxib
|
Drug: celecoxib
dose form
|
2: Experimental
overencapsulated celecoxib
|
Drug: celecoxib
dose form
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Research | |
Springfield, Missouri, United States |
Study Director: | Mark Sostek, MD | AstraZeneca |
Principal Investigator: | Christopher Billings, DO | Bio-Kinetic Clinical Applications, LLC |
Responsible Party: | AstraZeneca Pharmaceuticals ( Mark Sostek, MD, Medical Science Director, Development Project ) |
Study ID Numbers: | D1120C00007 |
Study First Received: | August 5, 2008 |
Last Updated: | May 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00729495 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Phase I, Healthy Volunteer Study |
Anti-Inflammatory Agents Celecoxib Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Healthy Antirheumatic Agents |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors 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 |