Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-04 @ 4:11 PM
Study NCT ID:
NCT03074058
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C119467', 'term': 'lanthanum carbonate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day', 'timeFrame': '6 days', 'description': 'Each study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.'}, {'measure': 'Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period', 'timeFrame': 'baseline and over 3-days', 'description': 'During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3', 'timeFrame': '1 day'}, {'measure': 'Plasma lanthanum concentrations (ng/mL)', 'timeFrame': '6 days', 'description': 'To measure plasma concentration of lanthanum, 6 mL of blood were collected before the breakfast on Day 1, Day 2, Day 3 and Day 4, and at 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours after administration on Day 4.'}, {'measure': 'Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}, {'measure': 'Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}, {'measure': 'Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}, {'measure': 'Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}, {'measure': 'Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}, {'measure': 'Number of adverse events as a measure of safety and tolarability', 'timeFrame': 'From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6)'}, {'measure': 'Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)', 'timeFrame': '6 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clinical Pharmacology']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)\n\nExclusion Criteria:\n\n* Regular use of medicines including Chinese herbal drugs\n* Clinically relevant findings in the physical examination\n* Subject who cannot take the study drug appropriately (e.g. weak biting force, insufficient salivary flow)'}, 'identificationModule': {'nctId': 'NCT03074058', 'briefTitle': 'Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet - Randomized, Open-label, Two-way Crossover Study to Establish the Bioequivalence Between BAY 77-1931 Orally Disintegrating Tablet 500 mg and Fosrenol Chewable Tablet 500 mg Administered in Japanese Healthy Male Adult Subjects', 'orgStudyIdInfo': {'id': '18060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)', 'description': 'Fosrenol BAY 77-1931 orally disintegrating tablet (ODT) 500 mg in Period 1 (day 1-3) and Fosrenol chewable tablet 500mg in Period 2 (day 4-6). The washout interval between period 1 and 2 will be at least 14 days.', 'interventionNames': ['Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)', 'description': 'Fosrenol BAY77-1931 chewable tablet in Period 1 and Fosrenol BAY 77-1931 ODT 500 mg in Period 2. The washout interval between period 1 and 2 will be at least 14 days.', 'interventionNames': ['Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)']}], 'interventions': [{'name': 'Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)', 'type': 'DRUG', 'description': 'Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID', 'armGroupLabels': ['Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)']}, {'name': 'Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)', 'type': 'DRUG', 'description': 'Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID', 'armGroupLabels': ['Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}