Pharmacokinetics of Curcumin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181662
First received: September 12, 2005
Last updated: April 2, 2007
Last verified: April 2007
  Purpose

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 Intervention
Healthy
Drug: Curcumin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Curcumin pharmacology

Secondary Outcome Measures:
  • Interactions between piperine and curcumin
  • Interactions between silybin and curcumin

Estimated Enrollment: 6
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • On no medications except for birth control pills
  • Signed informed consent

Exclusion Criteria:

  • Pregnant
  • Comorbid disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181662

Locations
United States, Massachusetts
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181662     History of Changes
Other Study ID Numbers: 2005P-000650, P50 CA105009-01
Study First Received: September 12, 2005
Last Updated: April 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Curcumin
Piperine
Silybin
Healthy volunteer
Female

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014