CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
Lanthanum carbonate Granule Formulation +1 moredrug
Likely dose
Lanthanum carbonate Granule Formulation 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00880750
NCT00880750Phase 1Completed
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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

Shire·interventional·Posted Apr 14, 2009·Updated Jun 11, 2021

In Brief

A Phase 1 clinical trial evaluating Lanthanum carbonate Granule Formulation and Lanthanum carbonate Chewable Tablets (Fosrenol) for End Stage Renal Disease. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2009
Enrollment StartJan 28, 2009
Primary CompletionJun 22, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.2 years ago

Interventions

Lanthanum carbonate Granule Formulationdrug

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.)

Lanthanum carbonate Chewable Tablets (Fosrenol)drug

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.)