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Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers

NCT01741519 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-04-21

No results posted yet for this study

Summary

The study will compare the pharmacokinetics (PK), safety and tolerability of long-term infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and adverse events (AEs).

Conditions

  • Healthy

Interventions

DRUG

LDLL600

Comparison of 3 different doses LDLL600 in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.

DRUG

Brevibloc

Comparison of 3 different doses Esmolol in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.

Sponsors & Collaborators

  • AOP Orphan Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Ivan Ulc, MD · Cepha s.r.o

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Czechia

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 NCT01741519 on ClinicalTrials.gov