Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 2:18 PM
Study NCT ID:
NCT01125657
Status:
COMPLETED
Last Update Posted:
2010-05-25
First Post:
2010-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-24', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of YM150 and its metabolites measured by blood sample', 'timeFrame': 'for 3 days after drug administration'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by AEs, vital signs, 12-lead ECG and lab tests', 'timeFrame': 'or 3 days after drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YM150', 'bioequivalence study'], 'conditions': ['Healthy Volunteer', 'Pharmacokinetics of YM150']}, 'descriptionModule': {'briefSummary': 'This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight: ≥50.0 kg, \\<80.0 kg\n* BMI: ≥17.6, \\<26.4\n* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests\n\nExclusion Criteria:\n\n* Received any investigational drugs within 120 days before the study\n* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study\n* Received medication within 7 days before the study\n* A deviation from the assessment criteria of physical examinations or laboratory tests\n* A deviation from the normal reference range of coagulation test \\[PT (INR) or aPTT\\]\n* History of drug allergies\n* Upper gastrointestinal disease within 7 days before the study\n* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases\n* Concurrent or previous malignant tumor\n* Previous treatment with YM150'}, 'identificationModule': {'nctId': 'NCT01125657', 'briefTitle': 'A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -', 'orgStudyIdInfo': {'id': '150-CL-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'formualation-A to -B sequence group', 'interventionNames': ['Drug: YM150']}, {'type': 'EXPERIMENTAL', 'label': 'formulation-B to -A sequence group', 'interventionNames': ['Drug: YM150']}], 'interventions': [{'name': 'YM150', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['formualation-A to -B sequence group', 'formulation-B to -A sequence group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyushu', 'country': 'Japan'}], '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'}}}}