Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00807118
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2008-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-23', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition', 'timeFrame': 'Day 1 and 2'}, {'measure': 'AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition', 'timeFrame': 'Day 1 and 2'}, {'measure': 'AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1)', 'timeFrame': 'Day 1 and 2'}], 'secondaryOutcomes': [{'measure': 'Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment', 'timeFrame': 'Day 1 and 2'}, {'measure': 'AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II', 'timeFrame': 'Day 1 and 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence, food effect'], 'conditions': ['Therapeutic Equivalency', 'Food']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221052&StudyName=Phase%201%2C%20single%20dose%2C%20crossover%20study%20to%20determine%20bioequivalence%20and%20to%20investigate%20food%20effect', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese healthy male subject\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant findings at screening'}, 'identificationModule': {'nctId': 'NCT00807118', 'briefTitle': 'Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects.', 'orgStudyIdInfo': {'id': 'A0221052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A (Cohort I)', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'EXPERIMENTAL', 'label': 'B (Cohort I)', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'EXPERIMENTAL', 'label': 'C (Cohort I)', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'EXPERIMENTAL', 'label': 'B (Cohort II)', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'EXPERIMENTAL', 'label': 'D (Cohort II)', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'EXPERIMENTAL', 'label': 'E (Cohort II)', 'interventionNames': ['Drug: Fesoterodine']}], 'interventions': [{'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 2 x 4 mg tab in formulation F under fed condition', 'armGroupLabels': ['A (Cohort I)']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 1 x 8 mg tab in formulation F under fed condition', 'armGroupLabels': ['B (Cohort I)']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 1 x 8 mg tab in formulation E(1) under fed condition', 'armGroupLabels': ['C (Cohort I)']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 1 x 8 mg tab in formulation F under fed condition', 'armGroupLabels': ['B (Cohort II)']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 2 x 4 mg tab in formulation F under fasted condition', 'armGroupLabels': ['D (Cohort II)']}, {'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single dose of 1 x 8 mg tab in formulation F under fasted condition', 'armGroupLabels': ['E (Cohort II)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shinjuku-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', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}