The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
Condition: Healthy
Intervention: Calcitriol; Lanthanum carbonate + Calcitriol; Sevelamer carbonate + Calcitriol
Intervention description: Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.; 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 (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.
Intervention MeSH terms: Calcitriol; Sevelamer
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        Inclusion criteria

          -  Healthy volunteers age 19-45 years inclusive at the time of consent.

          -  Satisfactory medical assessment with no clinically significant or relevant
             abnormalities in medical history, physical examination, vital signs, electrocardiogram
             (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by
             the Investigator.

          -  No current or recurrent disease (e.g. cardiovascular, renal, liver, gastrointestinal
             (GI), malignancy or other conditions) that could affect the action, absorption or
             disposition of the investigational products utilized in this study, or could affect
             clinical or laboratory assessments.

        Exclusion criteria

          -  Current or recurrent disease (eg, cardiovascular, renal, liver, GI, malignancy or
             other conditions) that could affect the action, absorption or disposition of the
             investigational products utilized in this study, or could affect clinical or
             laboratory assessments.

          -  Current or relevant previous of physical or psychiatric illness, any medical disorder
             that could have required treatment or made the subject unlikely to fully complete the
             study, or any condition that presented undue risk from the investigational product or
             study procedures.

          -  Current use of any medication with the exception of hormonal replacement therapy or
             hormonal contraceptives within 14 days of first dose of investigational product.

          -  History of alcohol or other substance abuse within the last year.

          -  A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen
             or Hepatitis C virus antibody screen.

          -  Use of tobacco in any form

          -  Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to
             receiving the first dose of investigational product.