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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
History of Changes
  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:

Drug Information available for: Curcumin
U.S. FDA Resources

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
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 May 23, 2013