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Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00729495
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 14, 2009
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
POZEN

Tracking Information
First Submitted Date  ICMJE August 5, 2008
First Posted Date  ICMJE August 7, 2008
Last Update Posted Date May 14, 2009
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2008)
Pharmacokinetics [ Time Frame: pre-dose, baseline and multiple times post-dose ]
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
 (submitted: August 6, 2008)
Safety [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE Drug: celecoxib
dose form
Other Name: Celebrex
Study Arms  ICMJE
  • Active Comparator: 1
    marketed celecoxib
    Intervention: Drug: celecoxib
  • Experimental: 2
    overencapsulated celecoxib
    Intervention: Drug: celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 6, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729495
Other Study ID Numbers  ICMJE D1120C00007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Sostek, MD, Medical Science Director, Development Project, AstraZeneca Pharmaceuticals
Study Sponsor  ICMJE POZEN
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Christopher Billings, DO Bio-Kinetic Clinical Applications, LLC
PRS Account POZEN
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP