MedTrace Logo

Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

NCT00729495 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-05-14

No results posted yet for this study

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

DRUG

celecoxib

dose form

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • POZEN

    lead INDUSTRY

Principal Investigators

  • Mark Sostek, MD · AstraZeneca

  • Christopher Billings, DO · Bio-Kinetic Clinical Applications, LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-08-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729495 on ClinicalTrials.gov