- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181662
Pharmacokinetics of Curcumin in Healthy Volunteers
October 30, 2020 updated by: Laura Sullivan, Massachusetts General Hospital
Evaluation of Naturally Occurring Inhibitors of UDP-glucuronyltransferase on the Oral Bioavailability of Curcumin in Normal Healthy Volunteers
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.
Study Overview
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 Type
Interventional
Enrollment
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy volunteer
- On no medications except for birth control pills
- Signed informed consent
Exclusion Criteria:
- Pregnant
- Comorbid disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Curcumin pharmacology
|
Secondary Outcome Measures
Outcome Measure |
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Interactions between piperine and curcumin
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Interactions between silybin and curcumin
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Seiden, M.D., Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2005
Primary Completion (Actual)
October 17, 2007
Study Completion (Actual)
October 17, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 2005P-000650
- P50CA105009-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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