Theracurmin vs Curcumin Bioavailability Study

December 4, 2019 updated by: Handok Inc.

A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults

A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Randomization, Open-label, 3-period, 6-sequence, Crossover, Single
  • Drug-free inverval : more than 7 days
  • Sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h

Study Type

Interventional

Enrollment (Actual)

24

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

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

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult 19 to 60 years
  2. BMI 18.0~30.0kg/m2 at screening
  3. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Exclusion Criteria

  1. A person with clinically significant disease corresponding to cardiovascular, respiratory, liver, kidney, digestive system, blood/tumor system, endocrine system, immune system, neuropsychiatry or who has a history within the last 6 months.
  2. A person with a history of gastrointestinal disease or surgery (except for simple cecal surgery or hernia surgery) that may affect the absorption of food for clinical research.
  3. Persons who have an irritable reaction to foods containing turmeric or other drugs and food.
  4. Those who took medicines within 7 days before the first intake of food for clinical research.
  5. Food for Clinical Research If you have consumed foods containing turmeric (eg, radishes, curry) within 7 days before the first intake of food, or you can't consume until the day of intake of food for the last clinical study.
  6. Those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research.
  7. Women who are pregnant or lactating during screening, or who plan to become pregnant during clinical research. A person who is deemed unsuitable for participating in this clinical study because of other reasons.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theracurmin CR-033P
1 Capsule with 150mL water, Single, curcumin 90mg/day
curcumin 90mg/day cross-over
Other Names:
  • Theracurmin CR-033P
  • Theracurmin CR-031P
  • Curcumin
Experimental: Theracurmin CR-031P
3 Capsule with 150mL water, Single, curcumin 90mg/day
curcumin 90mg/day cross-over
Other Names:
  • Theracurmin CR-033P
  • Theracurmin CR-031P
  • Curcumin
Experimental: Curcumin
1 Capsule with 150mL water, Single, curcumin 90mg/day
curcumin 90mg/day cross-over
Other Names:
  • Theracurmin CR-033P
  • Theracurmin CR-031P
  • Curcumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 12hours
Maximum concentration at steady state
12hours
AUC
Time Frame: 12hours
Area under the concentration-time curve at steady state
12hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: HyeWon Chung, Korea University Guro 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)

July 31, 2019

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

November 29, 2019

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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