| Trial ID: | L0868 |
| Source ID: | NCT00875017
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| Associated Drug: |
Lanthanum Carbonate
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| Title: |
Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00875017/results
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Lanthanum Carbonate|DRUG: Sevelamer
|
| Outcome Measures: |
Primary: Net Phosphorous Absorption, Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting)., 10 hours post-dose | Secondary: Net Phosphorous Binding, Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only. Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only., 10 hours post-dose|Net Calcium Absorption, Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting)., 10 hours post-dose
|
| Sponsor/Collaborators: |
Sponsor: Shire
|
| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1
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| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2009-04-20
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| Completion Date: |
2009-06-16
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| Results First Posted: |
2010-07-02
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| Last Update Posted: |
2021-06-15
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| Locations: |
West Coast Clinical Trials, Cypress, California, 90630, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00875017
|
