Status:
UNKNOWN
Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Chenland Nutritionals Inc.
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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(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%. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05334043
Start Date
March 23 2022
End Date
December 30 2022
Last Update
April 19 2022
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shanndong, China, 266003