Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
This study has been completed.
Sponsor:
POZEN
Collaborator:
AstraZeneca
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00729495
First received: August 5, 2008
Last updated: May 12, 2009
Last verified: May 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 5, 2008 | ||||||||
| Last Updated Date | May 12, 2009 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetics [ Time Frame: pre-dose, baseline and multiple times post-dose ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00729495 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Healthy Volunteer | ||||||||
| Intervention ICMJE | Drug: celecoxib
dose form
Other Name: Celebrex |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Completion Date | October 2008 | ||||||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00729495 | ||||||||
| Other Study ID Numbers ICMJE | D1120C00007 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mark Sostek, MD, Medical Science Director, Development Project, AstraZeneca Pharmaceuticals | ||||||||
| Study Sponsor ICMJE | POZEN | ||||||||
| Collaborators ICMJE | AstraZeneca | ||||||||
| Investigators ICMJE |
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| Information Provided By | POZEN | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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