Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib - Full Text View

Sponsor:	POZEN
Collaborator:	AstraZeneca
Information provided by:	POZEN
ClinicalTrials.gov Identifier:	NCT00729495

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 I

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:

Drug Information available for: Celecoxib

U.S. FDA Resources

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

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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012