Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 10:45 PM
Study NCT ID:
NCT01737203
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '9 days'}, {'measure': 'Diastolic and Systolic Blood Pressure', 'timeFrame': '9 days'}, {'measure': '12-lead electrocardiogram (ECG)', 'timeFrame': '9 days'}, {'measure': 'Pulse rate (PR)', 'timeFrame': '9 days'}, {'measure': 'Number of Participants With Laboratory Test Values of Potential Clinical Importance', 'timeFrame': '9 days'}, {'measure': 'Mean Residence Time(MRT)', 'timeFrame': '0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Viagra', 'ODT', 'bioquivalence'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481315&StudyName=Bioequivalence%20Study%20For%20Orally-Disintegrating%20Tablet%20Of%20Sildenafil', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese male subjects between the ages of 20 and 55 years.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Baseline orthostatic hypotension defined as a \\>=20 mm Hg reduction in systolic blood pressure (SBP), a \\>=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.\n* Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.'}, 'identificationModule': {'nctId': 'NCT01737203', 'briefTitle': 'Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition', 'orgStudyIdInfo': {'id': 'A1481315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Viagra', 'description': 'Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions', 'interventionNames': ['Drug: Viagra']}, {'type': 'EXPERIMENTAL', 'label': 'ODT without water', 'description': 'Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions', 'interventionNames': ['Drug: sildenafil ODT']}, {'type': 'EXPERIMENTAL', 'label': 'ODT with water', 'description': 'Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions', 'interventionNames': ['Drug: sildenafil ODT']}], 'interventions': [{'name': 'Viagra', 'type': 'DRUG', 'otherNames': ['sildenafil citrate'], 'description': '50 mg tablet on Day 1 of each period', 'armGroupLabels': ['Viagra']}, {'name': 'sildenafil ODT', 'type': 'DRUG', 'description': '50 mg tablet on Day 1 of each period', 'armGroupLabels': ['ODT without water']}, {'name': 'sildenafil ODT', 'type': 'DRUG', 'description': '50 mg tablet on Day 1 of each period', 'armGroupLabels': ['ODT with water']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}