Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00950404
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2009-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D013607', 'term': 'Tablets'}], '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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-T and Cmax of sildenafil', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'AUC0-Tmax and AUCinf of sildenafil', 'timeFrame': '1 month'}, {'measure': 'Tmax and half-life of sildenafil', 'timeFrame': '1 month'}, {'measure': 'adverse events', 'timeFrame': '3 weeks'}, {'measure': 'vital signs', 'timeFrame': '3 weeks'}, {'measure': 'laboratory parameters', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability Pharmacokinetic Formulation'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481273&StudyName=Bioavailability%20of%203%20sildenafil%20oral%20disintegrating%20tablet%20formulations%20compared%20to%20the%20standard%20oral%20tablet', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Weight: BMI from 17.5 to 30.5\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* A positive urine drug screen.'}, 'identificationModule': {'nctId': 'NCT00950404', 'briefTitle': 'Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.', 'orgStudyIdInfo': {'id': 'A1481273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Viagra 50 mg tablet, administered with water.', 'interventionNames': ['Drug: Viagra 50 mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation B ODT tablet 50 mg, administered without water.', 'interventionNames': ['Drug: Formulation B ODT tablet 50 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation C ODT tablet 50 mg, administered without water.', 'interventionNames': ['Drug: Formulation C ODT tablet 50 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation D ODT tablet 50 mg, administered without water.', 'interventionNames': ['Drug: Formulation D ODT tablet 50 mg']}], 'interventions': [{'name': 'Viagra 50 mg tablet', 'type': 'DRUG', 'description': 'Commercial tablet, 50 mg, single dose administered with water', 'armGroupLabels': ['Viagra 50 mg tablet, administered with water.']}, {'name': 'Formulation B ODT tablet 50 mg', 'type': 'DRUG', 'description': 'Oral disintegrating tablet (ODT), 50 mg, single dose administered without water', 'armGroupLabels': ['Formulation B ODT tablet 50 mg, administered without water.']}, {'name': 'Formulation C ODT tablet 50 mg', 'type': 'DRUG', 'description': 'ODT, 50 mg, single dose administered without water', 'armGroupLabels': ['Formulation C ODT tablet 50 mg, administered without water.']}, {'name': 'Formulation D ODT tablet 50 mg', 'type': 'DRUG', 'description': 'ODT, 50 mg, single dose, administered without water', 'armGroupLabels': ['Formulation D ODT tablet 50 mg, administered without water.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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'}}}}