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Pharmacokinetics of Curcumin in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181662
First Posted: September 16, 2005
Last Update Posted: April 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
  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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00181662     History of Changes
Other Study ID Numbers: 2005P-000650
P50CA105009-01 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: April 4, 2007
Last Verified: April 2007

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
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action