Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02485028
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C080598', 'term': 'dapoxetine'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'C528396', 'term': 'mirodenafil'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose', 'description': 'Cmax of dapoxetine and mirodenafil'}, {'measure': 'Area Under Curve (AUC)', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose', 'description': 'AUC of dapoxetine and mirodenafil'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose'}, {'measure': 't1/2', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose'}, {'measure': 'CL/F', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose'}, {'measure': 'Vd/F', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'During 22 days from first administration of period 1', 'description': 'Incidence rate of Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dapoxetine', 'Mirodenafil', 'DDI study'], 'conditions': ['Drug Interaction Potentiation']}, 'descriptionModule': {'briefSummary': 'Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male adults aged between 19 and 55\n* Body mass index (BMI) in the range of 19 to 27 kg/m2\n* Understand the requirements of the study and voluntarily consent to participate in the study\n* Available for the entire study period\n\nExclusion Criteria:\n\n* Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases\n* Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg \\> systolic blood pressure ≥ 140 mmHg, 60 mmHg \\> diastolic blood pressure ≥ 90 mmHg)\n* History of drug abuse\n* History of caffeine, alcohol, smoking abuse\n\n * caffeine(coffee,tea,coke)\\> 4cups/day\n * smoking \\> 10 cigarettes/day\n * alcohol \\> 140g/week\n* Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day\n* Previously donate whole blood within 60 days or component blood within 30 days\n* Subject has taken drugs which affects the ADME of investigational products\n* Subject with known for hypersensitivity reactions to mirodenafil/ dapoxetine or other drugs\n* Inadequate laboratory test result:\n\n * AST(SGOT) or ALT(SGPT) or total bilirubin \\> 1.5 x upper limit of normal range\n * eGFR \\< lower limit of normal range\n* Subject considered as unsuitable based on medical judgement by investigators'}, 'identificationModule': {'nctId': 'NCT02485028', 'briefTitle': 'Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'SID123_DDI_I_2013'}, 'secondaryIdInfos': [{'id': '12542', 'type': 'OTHER', 'domain': 'South Korea: Ministry of Food and Drug Safety'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M→D→D+M', 'description': 'Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'M→D+M→D', 'description': 'Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'D→M→D+M', 'description': 'Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'D+M→M→D', 'description': 'Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'D+M→D→M', 'description': 'Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'D→D+M→M', 'description': 'Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3', 'interventionNames': ['Drug: Dapoxetine 30mg tablet', 'Drug: Mirodenafil 50mg tablet']}], 'interventions': [{'name': 'Dapoxetine 30mg tablet', 'type': 'DRUG', 'armGroupLabels': ['D+M→D→M', 'D+M→M→D', 'D→D+M→M', 'D→M→D+M', 'M→D+M→D', 'M→D→D+M']}, {'name': 'Mirodenafil 50mg tablet', 'type': 'DRUG', 'armGroupLabels': ['D+M→D→M', 'D+M→M→D', 'D→D+M→M', 'D→M→D+M', 'M→D+M→D', 'M→D→D+M']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jae-Wook Ko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}