Clinical Trial Details
| Trial ID: | L1006 |
| Source ID: | NCT00880750 |
| Associated Drug: | Lanthanum Carbonate Granule Formulation |
| Title: | Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00880750/results |
| Conditions: | End Stage Renal Disease |
| Interventions: | DRUG: Lanthanum carbonate Granule Formulation|DRUG: Lanthanum carbonate Chewable Tablets (Fosrenol) |
| Outcome Measures: | Primary: Urinary Phosphate Excretion 3-Day Average, Continuous collection over 3 days | Secondary: Urinary Phosphate Excretion on Day 4, Continuous collection on Day 4|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 |
| Sponsor/Collaborators: | Sponsor: Shire |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 72 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2009-01-28 |
| Completion Date: | 2009-06-22 |
| Results First Posted: | 2010-03-11 |
| Last Update Posted: | 2021-06-11 |
| Locations: | West Coast Clinical Trials, LLC, Cypress, California, 90630, United States |
| URL: | https://clinicaltrials.gov/show/NCT00880750 |
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