Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT03327558
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2017-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum observed plasma concentration)', 'timeFrame': '3 hours after oral dose is taken', 'description': 'Maximum observed plasma concentration levels used for descriptive analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate and compare the bioavailability of mesalamine', 'detailedDescription': 'The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female, at least 18 years of age\n* Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)\n* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests\n\nExclusion Criteria:\n\n* Any contraindication to mesalamine according to the applicable labeling'}, 'identificationModule': {'nctId': 'NCT03327558', 'briefTitle': 'Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'VLU-P6-774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apriso 0.375G ER CAP', 'description': 'Apriso 0.375G ER Cap', 'interventionNames': ['Drug: Apriso 0.375G ER CAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'APRISO 375 mg extended-release capsules', 'description': 'APRISO 375 mg ER cap', 'interventionNames': ['Drug: APRISO 375 mg extended-release capsules']}], 'interventions': [{'name': 'Apriso 0.375G ER CAP', 'type': 'DRUG', 'description': 'ER capsule', 'armGroupLabels': ['Apriso 0.375G ER CAP']}, {'name': 'APRISO 375 mg extended-release capsules', 'type': 'DRUG', 'description': '375 mg extended-release capsules', 'armGroupLabels': ['APRISO 375 mg extended-release capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22434', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Valeant Site 01', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}