NCT00181662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2007

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

September 12, 2005

Last Update Submit

October 30, 2020

Conditions

Healthy

Keywords

CurcuminPiperineSilybinHealthy volunteerFemale

Outcome Measures

Primary Outcomes (1)

  • Curcumin pharmacology

Secondary Outcomes (2)

  • Interactions between piperine and curcumin

  • Interactions between silybin and curcumin

Interventions

CurcuminDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Comorbid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Michael Seiden, M.D., Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Official

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

August 1, 2005

Primary Completion

October 17, 2007

Study Completion

October 17, 2007

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

US(1)