Status:
COMPLETED
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Lead Sponsor:
POZEN
Collaborating Sponsors:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 yi...
Eligibility Criteria
Inclusion
- Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
- Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- Clinically normal physical exams and laboratory measurements
Exclusion
- Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study
- Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00729495
Start Date
July 1 2008
End Date
October 1 2008
Last Update
May 14 2009
Active Locations (1)
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1
Research
Springfield, Missouri, United States