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Pharmacokinetics of Inhaled Levosimendan

NCT06387862 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-05-20

No results posted yet for this study

Summary

Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.

Conditions

  • Left Ventricular Dysfunction

Interventions

DRUG

Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled

Each patient will receive 12µg/kg of levosimendan by inhalation over 10 min. During 10h following inhaled dose, plasma concentrations will be measured.

DRUG

Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous

Each patient will receive 12µg/kg of levosimendan by intravenous (IV) administration over 10 min and at the same timepoints plasma samples will be measured

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Matthias Raes, MD · Universitair Ziekenhuis Brussel

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-11-30
Completion
2025-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387862 on ClinicalTrials.gov