Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT01247805
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2010-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration.', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}, {'measure': 'Maximum sildenafil plasma concentration (Cmax)', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}], 'secondaryOutcomes': [{'measure': 'AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}, {'measure': 'AUC%extrapolated of sildenafil.', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}, {'measure': 'Tmax - time at which maximum sildenafil plasma concentration occurs', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}, {'measure': 'Adverse events', 'timeFrame': 'From FSFV to LSLV, up to 5 weeks'}, {'measure': 'terminal half-life of sildenafil.', 'timeFrame': 'Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Powder for oral suspention'], 'conditions': ['Pulmonary Arterial Hypertention']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481293&StudyName=A%20Pivotal%20Bioequivalence%20Study%20Between%20The%20Sildenafil%20Powder%20For%20Oral%20Suspension%20%2810%20Mg/Ml%29%20And%20The%20Sildenafil%2010%20Mg%20Immediate%20Relea', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.\n\n2\\. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n\n3\\. An informed consent document signed and dated by the subject or a legally acceptable representative.\n\n4\\. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.\n2. History of febrile illness within 5 days prior to the first dose.\n3. A positive urine drug screen.'}, 'identificationModule': {'nctId': 'NCT01247805', 'briefTitle': 'A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'A1481293'}, 'secondaryIdInfos': [{'id': 'EudraCT 2010-023521-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Revatio: 1 x 20 mg IR oral tablet.', 'interventionNames': ['Drug: sildenafil citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': '2 x 10 mg sildenafil citrate IR oral tablet.', 'interventionNames': ['Drug: Sildenafil citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': '2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).', 'interventionNames': ['Drug: sildenafil citrate']}], 'interventions': [{'name': 'sildenafil citrate', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'Single oral dose of 1 x 20 mg IR oral tablet.', 'armGroupLabels': ['Treatment A']}, {'name': 'Sildenafil citrate', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.', 'armGroupLabels': ['Treatment B']}, {'name': 'sildenafil citrate', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], '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'}}}}