Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT01331993
Status:
COMPLETED
Last Update Posted:
2011-10-18
First Post:
2011-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-17', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in area under the plasma concentration-time curve (AUC) from time zero to infinity', 'timeFrame': 'Pre-dose to Day 4'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with Adverse Events as a measure of Safety and Tolerability', 'timeFrame': 'Day 1'}, {'measure': 'Number of subjects with Adverse Events as a measure of Safety and Tolerability', 'timeFrame': 'Day 2'}, {'measure': 'Number of subjects with Adverse Events as a measure of Safety and Tolerability', 'timeFrame': 'Day 3'}, {'measure': 'Number of subjects with Adverse Events as a measure of Safety and Tolerability', 'timeFrame': 'Day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'crossover', 'bioequivalence', 'naproxen', 'esomeprazole', 'vimovo', 'healthy volunteers'], 'conditions': ['Healthy Volunteers', 'Bioequivalence']}, 'descriptionModule': {'briefSummary': 'The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.', 'detailedDescription': 'A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female volunteer, aged 18 - 55 years (inclusive)\n* Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.\n* Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study\n* Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)\n\nExclusion Criteria:\n\n* Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening\n* Uncontrolled hypertension defined as resting systolic pressure \\>140 mmHg or diastolic pressure \\>90 mmHg at screening or admission to Period 1\n* Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms\n* Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption'}, 'identificationModule': {'nctId': 'NCT01331993', 'briefTitle': 'A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1120C00030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Treatment order : A, B, C', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Treatment order : B, C, A', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Treatment order : C, A, B', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Treatment order : A, C, B', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Treatment order : B, A, C', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}, {'type': 'EXPERIMENTAL', 'label': '6', 'description': 'Treatment order : C, B, A', 'interventionNames': ['Drug: VIMOVO (AstraZeneca)', 'Drug: VIMOVO (Patheon)', 'Drug: Marketed enteric-coated naproxen formulation']}], 'interventions': [{'name': 'VIMOVO (AstraZeneca)', 'type': 'DRUG', 'otherNames': ['Treatment A'], 'description': 'VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}, {'name': 'VIMOVO (Patheon)', 'type': 'DRUG', 'otherNames': ['Treatment B'], 'description': 'VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}, {'name': 'Marketed enteric-coated naproxen formulation', 'type': 'DRUG', 'otherNames': ['Treatment C'], 'description': 'Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Stepehn Kanes', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca, Wilmington, USA'}, {'name': 'Kingsley Urakpo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}