NCT00925704

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

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®)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-31
• Completion: 2009-07-31
• First posted: 2009-06-22
• Last updated: 2021-06-15
• Results posted: 2010-05-14

Locations

1 site across 1 country: United States