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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: celecoxib

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States
      • Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; marketed celecoxib	Drug: celecoxib; dose form; Other Names: Celebrex
Experimental: 2; overencapsulated celecoxib	Drug: celecoxib; dose form; Other Names: Celebrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	pre-dose, baseline and multiple times post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	Throughout study

Collaborators and Investigators

• Sponsor: POZEN
• Collaborators: AstraZeneca
• Investigators: Study Director: Mark Sostek, MD, AstraZeneca; Principal Investigator: Christopher Billings, DO, Bio-Kinetic Clinical Applications, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 6, 2008
• First Posted (Estimate): August 7, 2008

Study Record Updates

• Last Update Posted (Estimate): May 14, 2009
• Last Update Submitted That Met QC Criteria: May 12, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Healthy; Volunteer; Phase I,; Study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: D1120C00007