Bioavailability of Curcumin Capsules in Healthy Adult Subjects

August 3, 2021 updated by: The Affiliated Hospital of Qingdao University

Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study

A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy adult male and female subjects under fasting conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upgraded curcumin capsules(CuminUP60®) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP60® capsule with that of curcumin capsule before the prescription improvement.

12 cases are planned to be enrolled.According to the random table, each subject will be randomly assigned to one of two groups (group 1: A/B, group 2: B/A). The cleaning period between the two doses is 7 days. Subjects were given the test preparation (A) or the control preparation (B) on the first day of the first cycle of the trial, and were temporarily allowed to leave the phase I clinical research center after 72 hours of blood sample collection and vital signs examination after the completion of the medication. After a 7-day wash period, on the 8th day of the second cycle, the subject will be cross-administered with the control formulation (B) or the test formulation (A), all procedures are the same as in the first cycle.

On the 11th day (the second cycle), subjects will undergo physical examination, ECG examination, assessment of vital signs (blood pressure, pulse, body temperature), laboratory examinations (blood biochemistry, blood routine, urine routine, detailed examination items are shown in the appendix 1) Female subjects must undergo a blood pregnancy test and then be allowed to leave the research center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

  • China
    • Shangdong
      • Qingdao, Shangdong, China, 266003
        • Phase I Clinical Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteer to participate in this clinical trial, understand and voluntarily signed a written informed consent;
  • Able to complete the research in accordance with the requirements of the test plan;
  • Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan within 3 months after the end of the study and voluntarily take effective contraceptive measures;
  • Male and female subjects aged 18 to 55 years old (including 18 and 55 years old);
  • Male subjects weigh no less than 50 kg. Female subjects weighed no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), and the body mass index is within the range of 18.0-28.0 (including the cut-off value).

Exclusion Criteria:

  • Abnormal conditions judged by clinicians to be clinically significant, which the research doctor considers not suitable for participants;
  • A positive test results for hepatitis B virus（HBV）, hepatitis C virus（HCV）, HIV or syphilis;
  • Those who have a history of specific allergies or allergies, or those who are known to be allergic to curcumin components or the like;
  • A history of alcoholism ;
  • A history of dysphagia or any gastrointestinal disease that affects drug absorption;
  • Female subjects are breastfeeding during the screening period or clinical trials or have a positive pregnancy test result;
  • Those who have a positive drug screening test or have a history of drug abuse in the past five years or have used drugs in the 3 months before taking the drug;
  • Those who smoked more than 5 cigarettes a day on average in the 3 months before the test;
  • Donate blood or blood loss ≥ 400ml within 3 months before taking the study drug;
  • Have a history of surgery or have taken the study drug within 3 months before taking the study drug;
  • Any prescription drugs taken within 14 days before taking the study drug;
  • Any over-the-counter medicines, herbal medicines or prescribe products taken within 7 days before taking the study drug;
  • Have taken a special diet or strenuous exercise or other drugs that affect the study within 48 hours before taking the study drug Those with factors such as absorption, distribution, metabolism, and excretion;
  • Consume chocolate, any caffeine-containing or xanthine-rich beverage or food (such as animal liver) within 48 hours before taking the study drug;
  • Those who have taken any alcohol-containing products within 24 hours before taking the study medication, or those who have been tested positive for alcohol;
  • Subjects judged by other researchers to be unsuitable to participate.

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CuminUP60®,then Curcumin capsules
Participants first received CuminUP60® 1600mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 1600mg on the eighth day in a fasting state.
Drug: CuminUP60®
4 capsules, 400 mg / capsule
Drug: Curcumin capsules
4 capsules, 400 mg / capsule
Experimental: Curcumin capsules,then CuminUP60®
Participants first received curcumin capsules 1600mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP60® 1600mg on the eighth day in a fasting state.
Drug: CuminUP60®
4 capsules, 400 mg / capsule
Drug: Curcumin capsules
4 capsules, 400 mg / capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax（Peak Plasma Concentration ）
Time Frame: Day 0 to Day 3
Maximum observed concentration,occurring at Tmax
Day 0 to Day 3
AUC（AUC0-t，AUC0-∞）
Time Frame: Day 0 to Day 3
Area under the plasma concentration versus time curve
Day 0 to Day 3
Tmax
Time Frame: Day 0 to Day 3
Time of Cmax
Day 0 to Day 3
F
Time Frame: Day 0 to Day 3
The rate and extent at which a drug is absorbed into the circulation of the body
Day 0 to Day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
tl/2
Time Frame: Day 0 to Day 3
Terminal half-life
Day 0 to Day 3
λz
Time Frame: Day 0 to Day 3
First Order Terminal Elimination Rate Constant
Day 0 to Day 3

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital of Qingdao University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chenland Nutritionals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yu Cao, Master, Qingdao University 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HT-PK-2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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