Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Phase 1
Completed
- Conditions
- End Stage Renal Disease
- Interventions
- Drug: Lanthanum carbonate Granule Formulation
- Registration Number
- NCT00880750
- Lead Sponsor
- Shire
- Brief Summary
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lanthanum carbonate granules Lanthanum carbonate Granule Formulation Lanthanum carbonate granulated formulation crossover to chewable tablet formulation Lanthanum carbonate chewable tablets (Fosrenol) Lanthanum carbonate Chewable Tablets (Fosrenol) Lanthanum carbonate chewable table formulation crossover to granulated formulation
- Primary Outcome Measures
Name Time Method Urinary Phosphate Excretion 3-Day Average Continuous collection over 3 days
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie lanthanum carbonate's phosphate-binding activity in end-stage renal disease?
How does lanthanum carbonate compare to sevelamer in phosphate control for CKD patients?
Are there specific biomarkers that predict lanthanum carbonate efficacy in hyperphosphatemia management?
What are the potential adverse events associated with lanthanum carbonate formulations in renal patients?
What are the pharmacokinetic differences between lanthanum carbonate granules and chewable tablets in Phase I trials?
Trial Locations
- Locations (1)
West Coast Clinical Trials, LLC
🇺🇸Cypress, California, United States
West Coast Clinical Trials, LLC🇺🇸Cypress, California, United States