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The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers

NCT00925704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-06-15

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Calcitriol

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

DRUG

Lanthanum carbonate + Calcitriol

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.

DRUG

Sevelamer carbonate + Calcitriol

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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-01
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925704 on ClinicalTrials.gov