NCT00880750

Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Lanthanum carbonate Granule Formulation	3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)
DRUG	Lanthanum carbonate Chewable Tablets (Fosrenol)	3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)

Timeline

• Start date: 2009-01-28
• Primary completion: 2009-06-22
• Completion: 2009-06-22
• First posted: 2009-04-14
• Last updated: 2021-06-11
• Results posted: 2010-03-11

Locations

1 site across 1 country: United States