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
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: celecoxib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: pre-dose, baseline and multiple times post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
marketed celecoxib
Drug: celecoxib
dose form
Other Name: Celebrex
Experimental: 2
overencapsulated celecoxib
Drug: celecoxib
dose form
Other Name: Celebrex

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Sostek, MD, Medical Science Director, Development Project, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00729495     History of Changes
Other Study ID Numbers: D1120C00007
Study First Received: August 5, 2008
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014