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Calcium per

Phase 1

Hyperphosphatemia | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Feb 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Calcium per · 1 trial · 1 indication

Phase 1 1
NCT00742820Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy VolunteersHyperphosphatemia
COMPLETED46 Analytics
PHASE1COMPLETED
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Serum Phosphate
24 hrs
Urinary Calcium
24 hrs

Secondary Endpoints

Serum Calcium
24 hrs
Urinary Phosphate
24 hrs
Serum insulin and glucose
6 hrs
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCalcium Acetate Oral Solution 667 mg per 5 mL
2ACTIVE_COMPARATORCalcium Acetate 667 mg Gelcaps
3OTHERCalcium Citrate 950 mg Caplets

Interventions

NameTypeDescription
Calcium Acetate Oral Solution 667 mg per 5 mLDRUGDrug: 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
Calcium Acetate 667 mg GelCapsDRUGDrug: 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.
Calcium Citrate 950 mg CapletsDIETARY_SUPPLEMENTDrug: 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
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed and dated informed consent form * Ages: 18-75 years * Serum Calcium level 8.6-10.2 mg/dL * 25 vitamin D level 20-100 ng/mL * 1, 25 dihydroxy vitamin D level 6-62 pg/mL * Fasting glucose level of 65-99 mg/dL (min 8 hr fast) * iPTH level of 10-65 pg/mL * Serum phosphorous...

Countries:United States
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