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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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