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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-08-01

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Sandimmune® Injection

DRUG

NeuroSTAT®

Sponsors & Collaborators

  • NeuroVive Pharmaceutical AB

    lead INDUSTRY

Principal Investigators

  • Eduard FW Krantz, Dr · Parexel

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • South Africa

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 NCT01692834 on ClinicalTrials.gov