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| 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 |
|---|---|---|
|
Healthy Volunteers |
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: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
|---|---|
|
Active Comparator: A
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
|
|
Experimental: B
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
|
|
Experimental: C
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
|
|
Experimental: D
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: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00813241 History of Changes |
| Other Study ID Numbers: | A3191354 |
| Study First Received: | December 22, 2008 |
| Last Updated: | March 1, 2010 |
| Health Authority: | Singapore: Health Sciences Authority |
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Ankylosing spondylitis,Rheumatoid Arthritis,Adenomatous Polyposis Coli,Osteoarthritis,Dysmenorrhoea,pharmacokinetic study |
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Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |