drugset / Trial / NCT01692834

A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy Volunteers

NCT01692834

Phase 1 Completed 65 enrolled NeuroVive Pharmaceutical AB
RandomizedCrossoverSingle-blind

Summary

To compare the bioavailability, pharmacokinetic profiles and the tolerability of two formulations of intravenous cyclosporine in healthy volunteers.

Timeline

Start
2009-06
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 5 mg/kg Intravenous

Indications

No indication recorded.