Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-31 @ 4:40 PM
Study NCT ID:
NCT01651858
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to Assess Pharmacokinetics', 'timeFrame': '24h after drug administration', 'description': 'AUC and Cmax in plasma'}], 'secondaryOutcomes': [{'measure': 'to Assess Safety', 'timeFrame': '24h after administration', 'description': 'Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy and male subjects aged 20 to 45 years\n* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)\n* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.\n\nExclusion Criteria:\n\n* A subject with sign or symptoms or previously diagnosed disease of liver'}, 'identificationModule': {'nctId': 'NCT01651858', 'briefTitle': 'Nurigra Chewable Tablet in Healthy Adult Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'Nurigra Chewable Tablet in Healthy Adult Male Volunteers', 'orgStudyIdInfo': {'id': 'DW_SDF001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurigra Chewable tablet', 'interventionNames': ['Drug: Nurigra Chewable tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Viagra', 'interventionNames': ['Drug: Nurigra Chewable tablet']}], 'interventions': [{'name': 'Nurigra Chewable tablet', 'type': 'DRUG', 'description': '1 tablet of 100mg, once a day', 'armGroupLabels': ['Nurigra Chewable tablet', 'Viagra']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}