Overview

Bioavailability of Curcumin Capsules in Healthy Adult Subjects

Status:
Completed
Trial end date:
2021-06-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborator:
Chenland Nutritionals Inc.
Treatments:
Curcumin
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.