Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-31 @ 2:23 PM
Study NCT ID:
NCT01392794
Status:
COMPLETED
Last Update Posted:
2011-07-13
First Post:
2011-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of YM060 plasma concentration -time curve', 'timeFrame': 'up to 24 hours after administration'}, {'measure': 'Maximal concentration of YM060 plasma concentration', 'timeFrame': 'up to 24 hours after administration'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG', 'timeFrame': 'up to 24 hours after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM060', 'ramosetron', 'orally-disintegrating tablet', 'OD tablet', 'bioequivalence'], 'conditions': ['Healthy', 'Plasma Concentration of YM060']}, 'descriptionModule': {'briefSummary': 'A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy assessed by the principal investigator or sub-investigators\n* non-smoking or stop smoking at least 90 days before the study\n* body weight: over 50.0kg and less than 80.0kg\n* body mass index (BMI): over 17.6 and less than 26.4\n\nExclusion Criteria:\n\n* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study\n* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study\n* received any drugs within 7 days before the study or going to receive any drugs\n* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG\n* deviance from normal range in lab-tests\n* history of drug allergy\n* history or current diagnosis of stomach, small intestine or large intestine diseases\n* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)\n* history or current diagnosis of colitis ischemic\n* history or current diagnosis of hepatic diseases\n* history or current diagnosis of cardiovascular diseases\n* history or current diagnosis of respiratory diseases\n* history or current diagnosis of malignant tumor\n* received ramosetron tablet"}, 'identificationModule': {'nctId': 'NCT01392794', 'briefTitle': 'A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water', 'orgStudyIdInfo': {'id': '060-CL-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'orally-disintegrating (OD) tablet precedence group', 'interventionNames': ['Drug: YM060']}, {'type': 'EXPERIMENTAL', 'label': 'conventional tablet precedence group', 'interventionNames': ['Drug: YM060']}], 'interventions': [{'name': 'YM060', 'type': 'DRUG', 'otherNames': ['ramosetron', 'Irribow'], 'description': 'oral, without water', 'armGroupLabels': ['conventional tablet precedence group', 'orally-disintegrating (OD) tablet precedence group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}