Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 9:28 AM
Study NCT ID:
NCT02447367
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological 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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast, Cmax, AUCinf', 'timeFrame': '192 hours'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': '192 hours'}, {'measure': 't1/2', 'timeFrame': '192 hours'}, {'measure': 'CL/F', 'timeFrame': '192 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['α1-blockers', 'antimuscarinic agent'], 'conditions': ['LUTS', 'Benign Prostatic Hyperplasia', 'Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.', 'detailedDescription': 'A randomized, open-label, single dose, two-way crossover study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 19\\~45 years healthy male\n* Body weight is over 55kg, BMI measurement 18.0kg/m\\^2\\~ 27.0kg/m\\^2\n* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.\n* Researchers determined suitable volunteers through physical examination, laboratory tests\n\nExclusion Criteria:\n\n* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)\n* Sitting SBP\\>150mmHg or \\<100mmHg, sitting DBP\\>100mmHg or \\<60mmHg, after 3 minutes break\n* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.\n* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)\n* History of drug abuse\n* Positive urine drug screening\n* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.\n* Donated blood within 60 days prior to the first administration day in this study."}, 'identificationModule': {'nctId': 'NCT02447367', 'briefTitle': 'Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'JLP-1207-P1-FE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JLP-1207, Fasted followed by fed', 'description': 'JLP-1207 dosing in the fasted state followed by fed dosing', 'interventionNames': ['Drug: JLP-1207(Fasted)']}, {'type': 'EXPERIMENTAL', 'label': 'JLP-1207, Fed followed by fasted', 'description': 'JLP-1207 dosing in the fed state followed by fasted dosing', 'interventionNames': ['Drug: JLP-1207(Fed)']}], 'interventions': [{'name': 'JLP-1207(Fasted)', 'type': 'DRUG', 'description': 'Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.', 'armGroupLabels': ['JLP-1207, Fasted followed by fed']}, {'name': 'JLP-1207(Fed)', 'type': 'DRUG', 'description': 'Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition', 'armGroupLabels': ['JLP-1207, Fed followed by fasted']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyung-sang Yu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital(SNUH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}