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This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLP 15 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
|
| CLP 25 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
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| CLP 7.5 g Fed | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack |
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| CLP 15 g fasted | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-Linked Polyelectrolyte (CLP) | Drug | CLP was administered orally, in capsules, for 9 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Net Sodium Balance | Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis. | Days 5 - 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fecal Weight | Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9) | Days 1-9 |
| Net Balance of Potassium, Magnesium, Calcium, and Phosphorous |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Blok, MD | Jasper Clinic, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic, Inc. | Kalamazoo | Michigan | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24460668 | Derived | Henderson LW, Dittrich HC, Strickland A, Blok TM, Newman R, Oliphant T, Albrecht D. A Phase 1 dose-ranging study examining the effects of a superabsorbent polymer (CLP) on fluid, sodium and potassium excretion in healthy subjects. BMC Pharmacol Toxicol. 2014 Jan 25;15:2. doi: 10.1186/2050-6511-15-2. |
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The net balance of cations was calculated based on dietary and fluid intake, urinary and fecal output, and emesis.
| Days 5-9 |
| Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper | Days 5-9 |
| Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous | Days 5-9 |
| Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous | Days 5-9 |