Clinical trial NCT04972045: Bioavailability of Curcumin Capsules in Healthy Adult Subjects
Official title: Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Chenland Nutritionals Inc.
First posted: 2021-07-22
Enrollment: 12
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax（Peak Plasma Concentration ）
timeFrame: Day 0 to Day 3
measure: AUC（AUC0-t，AUC0-∞）
timeFrame: Day 0 to Day 3
measure: Tmax
timeFrame: Day 0 to Day 3
measure: F
timeFrame: Day 0 to Day 3
Secondary outcomes:
measure: tl/2
timeFrame: Day 0 to Day 3
measure: λz
timeFrame: Day 0 to Day 3
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shangdong
Study officials:
affiliation: Qingdao University Hospital
name: Yu Cao, Master
role: STUDY_DIRECTOR
References: