Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT00729495
Status:
COMPLETED
Last Update Posted:
2009-05-14
First Post:
2008-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
Sponsor:
Organization:
Raw JSON
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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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit\n* 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\n* Clinically normal physical exams and laboratory measurements\n\nExclusion Criteria:\n\n* 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\n* 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\n* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption\n* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT00729495', 'briefTitle': 'Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib', 'organization': {'class': 'INDUSTRY', 'fullName': 'POZEN'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D1120C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'marketed celecoxib', 'interventionNames': ['Drug: celecoxib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'overencapsulated celecoxib', 'interventionNames': ['Drug: celecoxib']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'dose form', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'Mark Sostek, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Christopher Billings, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bio-Kinetic Clinical Applications, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'POZEN', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark Sostek, MD, Medical Science Director, Development Project', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}