Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00802451
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2008-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability', 'Mesalamine'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men or women, 18 to 55 years of age\n* weight within +/- 25% for height and weight for body frame\n* willing to participate and sign a copy of the informed consent form\n\nExclusion Criteria:\n\n* recent history of drug or alcohol addiction or abuse\n* pregnant or lactating women\n* history of allergic response to mesalamine\n* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant\n* receipt of any drugs as part of a research study within 28 days prior to study dosing'}, 'identificationModule': {'nctId': 'NCT00802451', 'briefTitle': 'Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Padagis LLC'}, 'officialTitle': 'A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations', 'orgStudyIdInfo': {'id': '10216928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test Drug', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Drug', 'interventionNames': ['Drug: Mesalamine']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'armGroupLabels': ['Reference Drug', 'Test Drug']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Padagis LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}