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Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

2019-10-08 08:47:37 | BioPortfolio

Summary

This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.

Description

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1 and be confined to the CRU until at least Day 8. On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections and ≥ 90% mass balance recovery, or ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which both are collected. If discharge criteria are not met by Day 8, subjects will remain in the CRU up to Day 12.

Study Design

Conditions

Healthy

Intervention

Saroglitazar magnesium

Location

Covance Clinical Research Unit Inc.
Madison
Wisconsin
United States
53704

Status

Recruiting

Source

Zydus Discovery DMCC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-08T08:47:37-0400

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Medical and Biotech [MESH] Definitions

Magnesium chloride. An inorganic compound consisting of one magnesium and two chloride ions. The compound is used in medicine as a source of magnesium ions, which are essential for many cellular activities. It has also been used as a cathartic and in alloys.

Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.

A nutritional condition produced by a deficiency of magnesium in the diet, characterized by anorexia, nausea, vomiting, lethargy, and weakness. Symptoms are paresthesias, muscle cramps, irritability, decreased attention span, and mental confusion, possibly requiring months to appear. Deficiency of body magnesium can exist even when serum values are normal. In addition, magnesium deficiency may be organ-selective, since certain tissues become deficient before others. (Harrison's Principles of Internal Medicine, 12th ed, p1936)

Inorganic compounds that contain magnesium as an integral part of the molecule.

A generic term for a variety of compounds that contain silicon, oxygen, and magnesium, and may contain hydrogen. Examples include TALC and some kinds of ASBESTOS.

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