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Pharmacokinetics of Curcumin in Healthy Volunteers

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.
 
ClinicalTrials.gov Identifier: NCT00181662
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Laura Sullivan, Massachusetts General Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
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 : August 2005
Actual Primary Completion Date : October 17, 2007
Actual Study Completion Date : October 17, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Curcumin pharmacology

Secondary Outcome Measures :
  1. Interactions between piperine and curcumin
  2. Interactions between silybin and curcumin

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Michael Seiden, M.D., Ph.D. Massachusetts General Hospital
More Information
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Responsible Party: Laura Sullivan, Study Official, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181662    
Other Study ID Numbers: 2005P-000650
P50CA105009-01 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Laura Sullivan, Massachusetts General Hospital:
Curcumin
Piperine
Silybin
Healthy volunteer
Female
Additional relevant MeSH terms:
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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