Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability of Curcumin Capsules in Healthy Adult Subjects

NCT04972045

Healthy Adult Subjects

COMPLETED PHASE1

A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product

NCT02474953

Healthy

COMPLETED PHASE1

Pharmacokinetics of Curcumin in Healthy Volunteers

NCT00181662

Healthy

COMPLETED NA

Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

NCT05542394

Plasma Levels of Different Curcuminoids Preparations

COMPLETED NA

Effects of 8 Weeks of Turmeric Ingestion on Physiology and Wellbeing in Healthy Older Adults

NCT07196514

Turmeric Placebo

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Upgraded curcumin capsules(CuminUP30) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 30%. CuminUP30 capsules are 500 mg/ capsules and ordinary curcumin capsules are 450 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP30 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects will be given test preparation (A) or control preparation (B) on the first day of the first cycle. After a 7-day washout period, on the 8th day of the second cycle, subjects will be cross-administered with the control preparation (B) or test preparation (A)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CuminUP30,then Curcumin capsules

Participants first received CuminUP30 3500mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 2250mg on the eighth day in a fasting state.

Group Type EXPERIMENTAL

CuminUP30

Intervention Type DRUG

7 capsules, 500 mg / capsule

Curcumin capsules

Intervention Type DRUG

5 capsules, 450 mg / capsule

Curcumin capsules,then CuminUP30

Participants first received curcumin capsules 2250mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP30 3500mg on the eighth day in a fasting state.

Group Type EXPERIMENTAL

CuminUP30

Intervention Type DRUG

7 capsules, 500 mg / capsule

Curcumin capsules

Intervention Type DRUG

5 capsules, 450 mg / capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CuminUP30

7 capsules, 500 mg / capsule

Intervention Type DRUG

Curcumin capsules

5 capsules, 450 mg / capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes