Evaluation of Liposomal Curcumin in Healthy Volunteers

Phase 1 Completed 50 enrolled SignPath Pharma, Inc.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2011-08
Primary completion: 2012-08
Completion: 2012-08

Publications

Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Bolger G, Helson L, Wolzt M. Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans. Int J Clin Pharmacol Ther. 2015 Jan;53(1):54-65. doi: 10.5414/CP202076.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Curcumin	Small molecule	10 mg/m2	Intravenous
Subject	Curcumin	Small molecule	20 mg/m2	Intravenous
Subject	Curcumin	Small molecule	40 mg/m2	Intravenous
Subject	Curcumin	Small molecule	80 mg/m2	Intravenous
Subject	Curcumin	Small molecule	120 mg/m2	Intravenous
Subject	Curcumin	Small molecule	180 mg/m2	Intravenous

Indications

No indication recorded.