Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02218658
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2014-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C020960', 'term': 'brotizolam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2014-08-15', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'Cmax (maximum plasma concentration)', 'timeFrame': 'up to 24 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 30 days'}, {'measure': 'tmax (time to maximum plasma concentration)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'MRT (Mean residence time)', 'timeFrame': 'up to 24 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 35 years\n* Weight between 50 and 80 kg\n* Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method\n* Judged as eligible as a study object following the screening test by the investigator\n* Volunteers to participate in the study, who are capable of giving written informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to drugs\n* History of drug or alcohol abuse\n* Received other investigational drug within 4 months of the trial drug administration\n* Had \\> 400 mL of whole blood drawn within 3 months of the trial drug administration\n* Had \\> 400 mL of blood components drawn within 1 month of the trial drug administration\n* Used any drug within 10 days of the trial drug administration\n* Engaged in strenuous exercise within 5 days of the trial drug administration\n* Consumed alcohol within 3 days of the trial drug administration\n* Judged as ineligible for the study participation by the investigator for a reason other than above'}, 'identificationModule': {'nctId': 'NCT02218658', 'briefTitle': 'Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) Taken Without Water and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis) Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)', 'orgStudyIdInfo': {'id': '263.507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WE 941 OD', 'interventionNames': ['Drug: WE941 OD tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brotizolam', 'interventionNames': ['Drug: Brotizolam']}], 'interventions': [{'name': 'WE941 OD tablets', 'type': 'DRUG', 'armGroupLabels': ['WE 941 OD']}, {'name': 'Brotizolam', 'type': 'DRUG', 'otherNames': ['Lendormin®'], 'armGroupLabels': ['Brotizolam']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}