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

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Calcitriol (Drug); Lanthanum carbonate + Calcitriol (Drug); Sevelamer carbonate + Calcitriol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Shire

Summary

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

Clinical Details

Official title: 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®)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol

Secondary outcome:

Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol

Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol

Eligibility

Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

West Coast Clinical Trials, Cypress, California 90630, United States
Additional Information

FDA recall information

Starting date: June 2009
Last updated: February 9, 2011

Page last updated: August 23, 2015

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