NCT01403545

Evaluation of Liposomal Curcumin in Healthy Volunteers

Safety, Tolerability and Pharmacokinetics of Liposomal Curcumin in Healthy Volunteers - A Phase I Dose Escalation Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: SignPath Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-07-27
• Last updated: 2014-05-26

Locations

1 site across 1 country: Austria