Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-29 @ 5:44 AM
Study NCT ID:
NCT00880750
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Sponsor:
Shire
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: