Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00742820
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C120662', 'term': 'calcium acetate'}, {'id': 'D019355', 'term': 'Calcium Citrate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Phosphate', 'timeFrame': '24 hrs'}, {'measure': 'Urinary Calcium', 'timeFrame': '24 hrs'}], 'secondaryOutcomes': [{'measure': 'Serum Calcium', 'timeFrame': '24 hrs'}, {'measure': 'Urinary Phosphate', 'timeFrame': '24 hrs'}, {'measure': 'Serum insulin and glucose', 'timeFrame': '6 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence'], 'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent form\n* Ages: 18-75 years\n* Serum Calcium level 8.6-10.2 mg/dL\n* 25 vitamin D level 20-100 ng/mL\n* 1, 25 dihydroxy vitamin D level 6-62 pg/mL\n* Fasting glucose level of 65-99 mg/dL (min 8 hr fast)\n* iPTH level of 10-65 pg/mL\n* Serum phosphorous level of 2.5-4.5 mg/dL\n* Albumin level of 3.6-5.1 g/dL\n* Sodium level of 135-146 mEq/L\n* Potassium level of 3.5-5.3 mEq/L\n* Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study\n* No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR\n* No clinically significant abnormalities on liver function tests\n* No clinically significant abnormalities on CBC and coagulation studies\n* No clinically significant abnormalities on kidney function (eGFR using serum creatinine)\n* BMI between 18.5-30\n* Subjects must agree not to consume alcohol while in the treatment phase of the study\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding\n* Malignancy except squamous cell carcinoma of the skin\n* Documented current acute or chronic disease\n* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C\n* Myocardial infarction within 6 months of study Day 0\n* Parathyroidectomy within 6 months of study Day 0\n* Gastrointestinal disorder associated with impaired absorption of oral medications\n* Inability to swallow tablets or tolerate calcium acetate oral solution\n* Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy\n* Concurrent antibiotic treatment\n* Any concurrent investigational treatment within 30 days of screening\n* Unable or unwilling to comply fully with the protocol\n* Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening\n* Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements\n* Subjects testing positive for drugs of abuse'}, 'identificationModule': {'nctId': 'NCT00742820', 'briefTitle': 'Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care North America'}, 'officialTitle': 'Randomized, Controlled, 3-Arm, Open Label, Cross-Over Bioequivalence Study Comparing Liquid PhosLo vs. PhosLo Gelcaps Using Calcium Citrate as a Positive Control in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LP-RTG-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Calcium Acetate Oral Solution 667 mg per 5 mL', 'interventionNames': ['Drug: Calcium Acetate Oral Solution 667 mg per 5 mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Calcium Acetate 667 mg Gelcaps', 'interventionNames': ['Drug: Calcium Acetate 667 mg GelCaps']}, {'type': 'OTHER', 'label': '3', 'description': 'Calcium Citrate 950 mg Caplets', 'interventionNames': ['Dietary Supplement: Calcium Citrate 950 mg Caplets']}], 'interventions': [{'name': 'Calcium Acetate Oral Solution 667 mg per 5 mL', 'type': 'DRUG', 'description': 'Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses', 'armGroupLabels': ['1']}, {'name': 'Calcium Acetate 667 mg GelCaps', 'type': 'DRUG', 'description': 'Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses.', 'armGroupLabels': ['2']}, {'name': 'Calcium Citrate 950 mg Caplets', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Antoinette A. Pragalos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jonathan Greenberg, MD, Director Clinical Research', 'oldOrganization': 'Fresenius USA Manufacturing Inc., d/b/a Fresenius Medical Care North America'}}}}