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.