Pharmacokinetics of Curcumin in Healthy Volunteers

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00181662
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Actual Duration (Months): 26.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of curcumin is also studied.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Curcumin	N/A

Detailed Description

Healthy volunteers are seen on three separate visits and receive 4 gm of curcumin as a single oral dose either alone or with piperine or with silybin. Serial timed blood draws then are collected for pharmacokinetic analysis.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Naturally Occurring Inhibitors of UDP-glucuronyltransferase on the Oral Bioavailability of Curcumin in Normal Healthy Volunteers
• Actual Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Oct 17, 2007
• Actual Study Completion Date: Oct 17, 2007

Outcome Measures

Primary Outcome Measures

1. Curcumin pharmacology []

Secondary Outcome Measures

1. Interactions between piperine and curcumin []

2. Interactions between silybin and curcumin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteer

• On no medications except for birth control pills

• Signed informed consent

Exclusion Criteria:

• Pregnant

• Comorbid disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Michael Seiden, M.D., Ph.D., Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Sullivan, Study Official, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00181662
• Other Study ID Numbers: 2005P-000650; P50CA105009-01
• First Posted: Sep 16, 2005
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Laura Sullivan, Study Official, Massachusetts General Hospital: Curcumin; Piperine; Silybin; Healthy volunteer; Female
• Additional relevant MeSH terms: Curcumin

Study Results

No Results Posted as of Nov 3, 2020