CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 41 enrolled
Drug / intervention
Calcitriol +2 moredrug
Likely dose
Calcitriol 1.0 microgramfrom 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/NCT00925704
NCT00925704Phase 1Completed
CompareCT.gov

A Phase I, Randomized, Open-Label, Three Period Cross-Over Study to Assess the Pharmacokinetics of Oral Calcitriol (ROCALTROL®) in Healthy Volunteers When Administered Alone or When Co-Administered With Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)

Shire·interventional·Posted Jun 22, 2009·Updated Jun 15, 2021

In Brief

A Phase 1 clinical trial evaluating Calcitriol, Lanthanum carbonate + Calcitriol, and 1 other intervention for Healthy. Completed, enrolled 41 participants across 1 site.

Detailed Summary

To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 31, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago

Interventions

Calcitrioldrug

Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.

Lanthanum carbonate + Calcitrioldrug

Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.

Sevelamer carbonate + Calcitrioldrug

Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.