|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00813241 |
Purpose
A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of three formulations of celecoxib to the approved formulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis Rheumatoid Arthritis Adenomatous Polyposis Coli Osteoarthritis Dysmenorrhoea |
Drug: celecoxib reference formulation Drug: celecoxib test formulation A1 Drug: celecoxib test formulation B2 Drug: celecoxib test formulation C1 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Formulations Of Celecoxib In Healthy Volunteers |
| Enrollment: | 16 |
| Study Start Date: | January 2009 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
A single dose of 200 mg celecoxib capsule administered as 1 x 200 mg celecoxib capsule, (Reference Formulation)
|
Drug: celecoxib reference formulation
200 mg single oral dose of celecoxib tablets
|
|
B: Experimental
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet formulation containing granule type A1
|
Drug: celecoxib test formulation A1
150 mg single oral dose of celecoxib A1 formulation tablets
|
|
C: Experimental
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type B2
|
Drug: celecoxib test formulation B2
150 mg single oral dose of celecoxib B2 formulation tablets
|
|
D: Experimental
A single dose of 150 mg celecoxib administered as 1 x 150 mg tablet containing granule type C1
|
Drug: celecoxib test formulation C1
150 mg single oral dose of celecoxib Cl formulation tablets
|
Pharmacokinetics
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A3191354 |
| Study First Received: | December 22, 2008 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00813241 History of Changes |
| Health Authority: | Singapore: Health Sciences Authority |
|
healthy volunteers, human experimentation, a pharmacokinetic study in of celecoxib in healthy volunteers |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Adenomatous Polyposis Coli Physiological Effects of Drugs Colonic Diseases Arthritis, Rheumatoid Pathologic Processes Neoplasms by Site Dysmenorrhea Therapeutic Uses Spondylitis, Ankylosing Spondylarthritis Spondylitis Ankylosis Spinal Diseases |
Digestive System Neoplasms Immune System Diseases Cyclooxygenase Inhibitors Bone Diseases, Infectious Neoplasms Gastrointestinal Neoplasms Colonic Neoplasms Neoplasms, Glandular and Epithelial Osteoarthritis Gastrointestinal Diseases Pain Infection Bone Diseases Signs and Symptoms Menstruation Disturbances |