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Evaluation of Liposomal Curcumin in Healthy Volunteers

NCT01403545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-05-26

No results posted yet for this study

Summary

Aim of the present study is:

* To evaluate the safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.
* To investigate the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.

Conditions

  • Drug Safety

Interventions

DRUG

Liposomal Curcumin

Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes

OTHER

Placebo

5% glucose infusion over 120 minutes

Sponsors & Collaborators

  • SignPath Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Wolzt, MD · Medical University of Vienna, Department of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Austria

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 NCT01403545 on ClinicalTrials.gov