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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:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: celecoxib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2008
Primary Completion Date : August 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
marketed celecoxib
Drug: celecoxib
dose form
Other Name: Celebrex
Experimental: 2
overencapsulated celecoxib
Drug: celecoxib
dose form
Other Name: Celebrex


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: pre-dose, baseline and multiple times post-dose ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729495


Locations
United States, Missouri
Research
Springfield, Missouri, United States
Sponsors and Collaborators
POZEN
AstraZeneca
Investigators
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Christopher Billings, DO Bio-Kinetic Clinical Applications, LLC
More Information

Responsible Party: Mark Sostek, MD, Medical Science Director, Development Project, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00729495     History of Changes
Other Study ID Numbers: D1120C00007
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by POZEN:
Phase I,
Healthy
Volunteer
Study

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents