Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-29 @ 5:44 AM
Study NCT ID:
NCT00880750
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119467', 'term': 'lanthanum carbonate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4', 'otherNumAtRisk': 71, 'otherNumAffected': 9, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4', 'otherNumAtRisk': 61, 'otherNumAffected': 6, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Phosphate Excretion 3-Day Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}], 'classes': [{'categories': [{'measurements': [{'value': '16.01', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '17.35', 'spread': '0.484', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.35', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '-0.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Continuous collection over 3 days', 'unitOfMeasure': 'mmol', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.'}, {'type': 'SECONDARY', 'title': 'Urinary Phosphate Excretion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}], 'classes': [{'categories': [{'measurements': [{'value': '15.03', 'spread': '0.569', 'groupId': 'OG000'}, {'value': '17.01', 'spread': '0.569', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.98', 'ciLowerLimit': '-3.17', 'ciUpperLimit': '-0.80', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Continuous collection on Day 4', 'unitOfMeasure': 'mmol', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PD set'}, {'type': 'SECONDARY', 'title': 'Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS means', 'ciPctValue': '90', 'paramValue': '1.34', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.42', 'groupDescription': 'The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.'}], 'paramType': 'MEAN', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}], 'classes': [{'categories': [{'measurements': [{'value': '0.638', 'spread': '0.241', 'groupId': 'OG000'}, {'value': '0.504', 'spread': '0.181', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric LS means', 'ciPctValue': '90', 'paramValue': '1.26', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.33', 'groupDescription': 'The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'After application of the log transformation Cmax was analysed using a mixed effect linear model.'}], 'paramType': 'MEAN', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate Granules', 'description': 'Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate Chewable Tablet', 'description': 'Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.00'}, {'value': '4.00', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.50', 'statisticalMethod': 'Wilcoxon (Hodges-Lehmann)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test"}], 'paramType': 'MEDIAN', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lanthanum Carbonate Granules First', 'description': 'Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.'}, {'id': 'FG001', 'title': 'Lanthanum Carbonate Chewable Tablet First', 'description': 'Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to collect urine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with meals', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to collect urine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lanthanum Carbonate Granules First', 'description': 'Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.'}, {'id': 'BG001', 'title': 'Lanthanum Carbonate Chewable Tablet First', 'description': 'Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '8.70', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '7.83', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '8.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2009-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2009-04-13', 'resultsFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2009-04-13', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-19', 'studyFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Phosphate Excretion 3-Day Average', 'timeFrame': 'Continuous collection over 3 days'}], 'secondaryOutcomes': [{'measure': 'Urinary Phosphate Excretion on Day 4', 'timeFrame': 'Continuous collection on Day 4'}, {'measure': 'Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4'}, {'measure': 'Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate', 'timeFrame': '3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End stage Renal disease'], 'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '22657252', 'type': 'RESULT', 'citation': 'Pierce D, Hossack S, Robinson A, Zhang P, Martin P. Assessment of pharmacodynamic equivalence and tolerability of lanthanum carbonate oral powder and tablet formulations: a single-center, randomized, open-label, 2-period crossover study in healthy subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA recall information'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Ability to provide informed consent to participate in the study.\n* Healthy volunteers, age 18-55 inclusive.\n* Subject must be willing to comply with applicable contraceptive requirements of the protocol\n* Female subjects must have a negative pregnancy test\n* Ability to chew and or swallow doses of the investigational products as prescribed in the protocol.\n* Ability to fully comply with all study procedures and restrictions, including consumption of all food provided while a resident in the CRC.\n\nExclusion Criteria\n\n* Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.\n* Clinically significant abnormal serum phosphate levels, outside of normal limits.\n* Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product.\n* A known history of lactose intolerance or allergy to milk or other foods.\n* Clinically significant or multiple allergies as determined by an Investigator.\n* History of alcohol or other substance abuse within the last 6 months.\n* A positive screen for alcohol or drugs of abuse.\n* Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day.\n* A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.\n* Female subjects who are pregnant (positive pregnancy test), lactating, or less than 90 days post-partum.\n* Subjects that have previously been randomized in this study.\n* Use of tobacco in any form or other nicotine-containing products in any form. Ex-users must report that they have stopped using tobacco for at least 60 days prior to receiving the first dose of investigational product.\n* Routine consumption of more than two units of caffeine per day or subjects who experience caffeine withdrawal headaches.\n* Donation of blood or blood products within 60 days prior to receiving the first dose of investigational product.\n* Plasma donation within 28 days prior to the first dose of the investigational product.\n* Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.'}, 'identificationModule': {'nctId': 'NCT00880750', 'briefTitle': 'Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'SPD405-127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lanthanum carbonate granules', 'description': 'Lanthanum carbonate granulated formulation crossover to chewable tablet formulation', 'interventionNames': ['Drug: Lanthanum carbonate Granule Formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Lanthanum carbonate chewable tablets (Fosrenol)', 'description': 'Lanthanum carbonate chewable table formulation crossover to granulated formulation', 'interventionNames': ['Drug: Lanthanum carbonate Chewable Tablets (Fosrenol)']}], 'interventions': [{'name': 'Lanthanum carbonate Granule Formulation', 'type': 'DRUG', 'description': "3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)", 'armGroupLabels': ['Lanthanum carbonate granules']}, {'name': 'Lanthanum carbonate Chewable Tablets (Fosrenol)', 'type': 'DRUG', 'otherNames': ['Fosrenol'], 'description': "3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)", 'armGroupLabels': ['Lanthanum carbonate chewable tablets (Fosrenol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials, LLC', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}