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
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 7, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 14, 2009
May 1, 2009
1 month
August 5, 2008
May 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
pre-dose, baseline and multiple times post-dose
Secondary Outcomes (1)
Safety
Throughout study
Study Arms (2)
1
ACTIVE COMPARATORmarketed celecoxib
2
EXPERIMENTALoverencapsulated celecoxib
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POZENlead
- AstraZenecacollaborator
Study Sites (1)
Research
Springfield, Missouri, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Sostek, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Christopher Billings, DO
Bio-Kinetic Clinical Applications, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 7, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2008
Study Completion
October 1, 2008
Last Updated
May 14, 2009
Record last verified: 2009-05