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This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLP 15 g QD | Experimental | Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime |
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| CLP 7.5 g BID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner |
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| CLP 5 g TID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner |
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| CLP 3.75 g QID | Experimental | Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-Linked Polyelectrolyte (CLP) | Drug | CLP was administered orally, in capsules, for 7 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal sodium content | The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period. | Baseline (Days 3-6) vs. Treatment (Days 10-13) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanthini A. Daniel, MD | Jasper Clinic, Inc. | Principal Investigator |
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