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Theracurmin vs Curcumin Bioavailability Study

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: NCT04028739
Recruitment Status : Active, not recruiting
First Posted : July 23, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Handok Inc.

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

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: curmin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Theracurmin CR-033P
1 Capsule with 150mL water, Single, curcumin 90mg/day
Dietary Supplement: curmin
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
Dietary Supplement: curmin
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
Dietary Supplement: curmin
curcumin 90mg/day cross-over
Other Names:
  • Theracurmin CR-033P
  • Theracurmin CR-031P
  • Curcumin




Primary Outcome Measures :
  1. Cmax [ Time Frame: 12hours ]
    Maximum concentration at steady state

  2. AUC [ Time Frame: 12hours ]
    Area under the concentration-time curve at steady state



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04028739


Locations
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Korea, Republic of
Korea Kuro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Inc.
Investigators
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Principal Investigator: Hyewon Chung Korea University Guro Hospital

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Responsible Party: Handok Inc.
ClinicalTrials.gov Identifier: NCT04028739     History of Changes
Other Study ID Numbers: TC_BA
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enzyme Inhibitors
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
Molecular Mechanisms of Pharmacological Action