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 ; An Open-label, Subject-blind, Laboratory-blind, Single-dose (5 mg/kg Infusion), Randomised, Two-period Crossover Tolerability Study Carried Out in Healthy Male and Female Subjects
Phase of Trial: Phase I
Latest Information Update: 20 Sep 2012
At a glance
- Drugs Ciclosporin (Primary)
- Indications Amyotrophic lateral sclerosis; Chronic brain damage; Stroke
- Focus Pharmacokinetics
- Sponsors NeuroVive Pharmaceutical
- 20 Sep 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health: NCT01692834).
- 30 Mar 2010 Primary endpoint 'Drug-bioavailability' has been met.
- 30 Mar 2010 Status changed from active, no longer recruiting to completed as reported in a Neurovive media release.