NCT00729495

Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	celecoxib	dose form

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2008-08-07
• Last updated: 2009-05-14

Locations

1 site across 1 country: United States