Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01521767
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2012-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Relative Bioavailability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of tolterodine', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of 5-HMT', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Plasma Decay Half-Life (t1/2) of tolterodine', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}, {'measure': 'Plasma Decay Half-Life (t1/2) of 5-HMT', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'relative bioavailability', 'tolterodine microspheres in powder blend', 'Overactive Urinary Bladder'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121196&StudyName=Pharmacokinetics%20and%20Relative%20Bioavailability%20Study%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules', 'detailedDescription': 'Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant diseases'}, 'identificationModule': {'nctId': 'NCT01521767', 'briefTitle': 'Pharmacokinetics and Relative Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules', 'orgStudyIdInfo': {'id': 'A6121196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '4 mg tolterodine extended release capsules, administered with water and under fasting condition.', 'interventionNames': ['Drug: tolterodine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': '4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.', 'interventionNames': ['Drug: tolterodine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': '4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.', 'interventionNames': ['Drug: tolterodine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': '4 mg MPB-RR1, administered without water and under fed condition.', 'interventionNames': ['Drug: tolterodine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'description': '4 mg MPB-RR1, administered with water and under fasting condition.', 'interventionNames': ['Drug: tolterodine tartrate']}], 'interventions': [{'name': 'tolterodine tartrate', 'type': 'DRUG', 'description': '4 mg single dose of extended release capsules', 'armGroupLabels': ['A']}, {'name': 'tolterodine tartrate', 'type': 'DRUG', 'description': '4 mg single dose of microspheres in powder blend', 'armGroupLabels': ['B']}, {'name': 'tolterodine tartrate', 'type': 'DRUG', 'description': '4 mg single dose of microspheres in powder blend', 'armGroupLabels': ['C']}, {'name': 'tolterodine tartrate', 'type': 'DRUG', 'description': '4 mg single dose of microspheres in powder blend', 'armGroupLabels': ['D']}, {'name': 'tolterodine tartrate', 'type': 'DRUG', 'description': '4 mg single dose of microspheres in powder blend', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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'}}}}