Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT02160158
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526675', 'term': 'fesoterodine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]', 'timeFrame': '48 hours', 'description': 'AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '48 hours', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '48 hours'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '48 hours', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fesoterodine', 'SR3', 'SR4', 'bioavailability', 'pharmacokinetics', 'sprinkle', 'applesauce'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221099&StudyName=Study%20to%20Estimate%20the%20Relative%20Bioavailability%20Compared%20to%20Commercial%20Extended-release%20Tablet%20Formulation%20and%20the%20Effects%20of%20Food%20Or%20Sprin', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years; 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* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication\n* History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon\n* Evidence or history of clinically significant urologic disease \\[urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day'}, 'identificationModule': {'nctId': 'NCT02160158', 'briefTitle': 'Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A0221099'}, 'secondaryIdInfos': [{'id': '2014-001248-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Drug: Fesoterodine ER (fasted)', 'Drug: Fesoterodine SR3 (fasted)', 'Drug: Fesoterodine SR3 (fed)', 'Drug: Fesoterodine ER (fed)', 'Drug: Fesoterodine SR3 (sprinkle)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'interventionNames': ['Drug: Fesoterodine ER (fasted)', 'Drug: Fesoterodine SR4 (fasted)', 'Drug: Fesoterodine SR4 (fed)', 'Drug: Fesoterodine ER (fed)', 'Drug: Fesoterodine SR4 (sprinkle)']}], 'interventions': [{'name': 'Fesoterodine ER (fasted)', 'type': 'DRUG', 'description': 'Commercial Fesoterodine ER 4 mg (single dose)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Fesoterodine SR3 (fasted)', 'type': 'DRUG', 'description': 'Fesoterodine SR3 4 mg (single dose)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Fesoterodine SR3 (fed)', 'type': 'DRUG', 'description': 'Fesoterodine SR3 4 mg (single dose) with high-fat meal', 'armGroupLabels': ['Cohort 1']}, {'name': 'Fesoterodine ER (fed)', 'type': 'DRUG', 'description': 'Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal', 'armGroupLabels': ['Cohort 1']}, {'name': 'Fesoterodine SR3 (sprinkle)', 'type': 'DRUG', 'description': 'Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce', 'armGroupLabels': ['Cohort 1']}, {'name': 'Fesoterodine ER (fasted)', 'type': 'DRUG', 'description': 'Commercial Fesoterodine ER 4 mg (single dose)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Fesoterodine SR4 (fasted)', 'type': 'DRUG', 'description': 'Fesoterodine SR4 4 mg (single dose)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Fesoterodine SR4 (fed)', 'type': 'DRUG', 'description': 'Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal', 'armGroupLabels': ['Cohort 2']}, {'name': 'Fesoterodine ER (fed)', 'type': 'DRUG', 'description': 'Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal', 'armGroupLabels': ['Cohort 2']}, {'name': 'Fesoterodine SR4 (sprinkle)', 'type': 'DRUG', 'description': 'Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}