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Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone

NCT01849094 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-01-14

No results posted yet for this study

Summary

To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone and to demonstrate evidence of hemodynamic effect

Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort) - to demonstrate evidence of haemodynamic benefit

Study Design: Open label

Conditions

Interventions

DRUG

Milrinone 6mg

Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements

DRUG

milrinone 10mg ER

Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements

DRUG

milrinone 14mg

Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements

Sponsors & Collaborators

  • The Alfred

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01849094 on ClinicalTrials.gov