Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00729495
First received: August 5, 2008
Last updated: May 12, 2009
Last verified: May 2009

August 5, 2008
May 12, 2009
July 2008
August 2008   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: pre-dose, baseline and multiple times post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729495 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Volunteer
Drug: celecoxib
dose form
Other Name: Celebrex
  • Active Comparator: 1
    marketed celecoxib
    Intervention: Drug: celecoxib
  • Experimental: 2
    overencapsulated celecoxib
    Intervention: Drug: celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729495
D1120C00007
No
Mark Sostek, MD, Medical Science Director, Development Project, AstraZeneca Pharmaceuticals
POZEN
AstraZeneca
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Christopher Billings, DO Bio-Kinetic Clinical Applications, LLC
POZEN
May 2009

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