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To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Calcium Acetate Oral Solution 667 mg per 5 mL |
|
| 2 | Active Comparator | Calcium Acetate 667 mg Gelcaps |
|
| 3 | Other | Calcium Citrate 950 mg Caplets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Acetate Oral Solution 667 mg per 5 mL | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Phosphate | 24 hrs | |
| Urinary Calcium | 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Calcium | 24 hrs | |
| Urinary Phosphate | 24 hrs | |
| Serum insulin and glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoinette A. Pragalos, MD | Community Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Research | Cincinnati | Ohio | 45206 | United States |
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|
| Calcium Acetate 667 mg GelCaps | Drug | 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. |
|
| Calcium Citrate 950 mg Caplets | Dietary Supplement | 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 |
|
| 6 hrs |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C120662 | calcium acetate |
| D019355 | Calcium Citrate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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