Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-03 @ 5:03 PM
Study NCT ID:
NCT01885520
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2013-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2013-06-15', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '0-24h'}, {'measure': 'Cmax', 'timeFrame': '0-24h'}], 'secondaryOutcomes': [{'measure': 'T1/2', 'timeFrame': '0-24h'}, {'measure': 'Tmax', 'timeFrame': '0-24h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet', 'detailedDescription': 'eperisone hydrochloride(muscle relaxant)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects age between 20 and 55 signed informed consent\n\nExclusion Criteria:\n\n* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs'}, 'identificationModule': {'nctId': 'NCT01885520', 'acronym': 'eperisone', 'briefTitle': 'Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'NVP Healthcare'}, 'officialTitle': 'A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.', 'orgStudyIdInfo': {'id': 'NVP-EPT-PK-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fasting condition', 'description': 'eperisone SR administrated under fasting condition', 'interventionNames': ['Dietary Supplement: fasting condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fed condition', 'description': 'eperisone SR administrated under fed condition', 'interventionNames': ['Dietary Supplement: fed condition']}], 'interventions': [{'name': 'fasting condition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'eperisone SR tablet 75mg administrated under fasting', 'armGroupLabels': ['fasting condition']}, {'name': 'fed condition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'eperisone SR tablet 75mg administrated fed condition', 'armGroupLabels': ['Fed condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Jung-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital'}], 'overallOfficials': [{'name': 'Yoon Yo Ran, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NVP Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}