Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT01514903
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC and Cmax of sildenafil', 'timeFrame': 'Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anti erectile dysfunction agent'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 20 and 45\n* weight : over 55kg and 18.5 \\< BMI, 25.0\n* have to give their consent to participating clinical trial by oneself\n\nExclusion Criteria:\n\n* has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \\> 430ms or uncontrolled arrhythmia'}, 'identificationModule': {'nctId': 'NCT01514903', 'briefTitle': 'Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'orgStudyIdInfo': {'id': 'HM-SIL-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'viagra,anti-erectile dysfunction agent', 'interventionNames': ['Drug: viagra']}, {'type': 'EXPERIMENTAL', 'label': 'HIP0908', 'interventionNames': ['Drug: HIP0908']}], 'interventions': [{'name': 'HIP0908', 'type': 'DRUG', 'description': 'SINGLE DOSE , CROSS OVER', 'armGroupLabels': ['HIP0908']}, {'name': 'viagra', 'type': 'DRUG', 'description': 'single dose, cross over', 'armGroupLabels': ['viagra,anti-erectile dysfunction agent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sinchon Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}