Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-04-17 @ 12:09 PM
Study NCT ID:
NCT01405157
Status:
WITHDRAWN
Last Update Posted:
2018-10-23
First Post:
2011-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf (area under the concentration time curve to infinity)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose'}, {'measure': 'Cmax (maximum concentration)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose'}], 'secondaryOutcomes': [{'measure': 'AUClast (area under the concentration time curve to last time point)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose'}, {'measure': 'Tmax (time at maximum concentration)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose'}, {'measure': 'Half-life', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence study', 'methylprednisolone', 'suspension', 'tablets', 'fasting'], 'conditions': ['Therapeutic Equivalency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0121007&StudyName=A%20Bioequivalence%20Study%20Comparing%20Methylprednisolone%20Suspension%20To%20Methylprednisolone%20Tablets%20Under%20Fasting%20Conditions%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects between the ages of 21 and 55 years.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \\> 45 kg (99 lbs).\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption (eg, gastrectomy).\n* A positive uring drug screen.'}, 'identificationModule': {'nctId': 'NCT01405157', 'briefTitle': 'A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'B0121007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'methylprednisolone suspension', 'interventionNames': ['Drug: methylprednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'methylprednisolone tablets', 'interventionNames': ['Drug: methylprednisolone']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'constituted powder for oral suspension 4 mg/mL single dose at 16 mg', 'armGroupLabels': ['methylprednisolone suspension']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'tablets 16 mg single dose', 'armGroupLabels': ['methylprednisolone tablets']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}