drugset / Trial / NCT01741519
Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers
RandomizedCrossoverQuadruple-blindTreatment
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).
Timeline
- Start
- 2012-12
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Esmolol | Other / unclassified | 50 ug/kg | Intravenous |
| Comparator | Esmolol | Other / unclassified | 100 ug/kg | Intravenous |
| Comparator | Esmolol | Other / unclassified | 200 ug/kg | Intravenous |
| Subject | Landiolol | Small molecule | 10 ug/kg | Intravenous |
| Subject | Landiolol | Small molecule | 20 ug/kg | Intravenous |
| Subject | Landiolol | Small molecule | 40 ug/kg | Intravenous |
Indications
No indication recorded.