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Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

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

Condition(s) targeted: End Stage Renal Disease

Intervention: Lanthanum carbonate Granule Formulation (Drug); Lanthanum carbonate Chewable Tablets (Fosrenol) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Shire

Summary

This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.

Clinical Details

Official title: A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects

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

Primary outcome: Urinary Phosphate Excretion 3-Day Average

Secondary outcome:

Urinary Phosphate Excretion on Day 4

Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate

Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate

Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Ability to provide informed consent to participate in the study.

- Healthy volunteers, age 18-55 inclusive.

- Subject must be willing to comply with applicable contraceptive requirements of the

protocol

- Female subjects must have a negative pregnancy test

- Ability to chew and or swallow doses of the investigational products as prescribed in

the protocol.

- Ability to fully comply with all study procedures and restrictions, including

consumption of all food provided while a resident in the CRC. Exclusion Criteria

- Current or relevant previous history of physical or psychiatric illness, any medical

disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.

- Clinically significant abnormal serum phosphate levels, outside of normal limits.

- Current use of any medication with the exception of hormonal replacement therapy or

hormonal contraceptives within 7 days of first dose of investigational product.

- A known history of lactose intolerance or allergy to milk or other foods.

- Clinically significant or multiple allergies as determined by an Investigator.

- History of alcohol or other substance abuse within the last 6 months.

- A positive screen for alcohol or drugs of abuse.

- Male subjects who consume more than 21 units of alcohol per week or three units per

day. Female subjects who consume more than 14 units of alcohol per week or two units per day.

- A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface

antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.

- Female subjects who are pregnant (positive pregnancy test), lactating, or less than

90 days post-partum.

- Subjects that have previously been randomized in this study.

- Use of tobacco in any form or other nicotine-containing products in any form.

Ex-users must report that they have stopped using tobacco for at least 60 days prior to receiving the first dose of investigational product.

- Routine consumption of more than two units of caffeine per day or subjects who

experience caffeine withdrawal headaches.

- Donation of blood or blood products within 60 days prior to receiving the first dose

of investigational product.

- Plasma donation within 28 days prior to the first dose of the investigational

product.

- Use of another investigational product within 30 days prior to receiving the first

dose of investigational product or active enrolment in another drug or vaccine clinical study.

Locations and Contacts

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

FDA recall information

Starting date: April 2009
Last updated: March 3, 2015

Page last updated: August 23, 2015

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