Bioavailability of Curcumin Capsules in Healthy Adult Subjects

NCT04972045 | Completed Phase 1

• 1 other identifier: HT-PK-2021-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (4)

• Cmax（Peak Plasma Concentration ）

  Maximum observed concentration,occurring at Tmax

  Day 0 to Day 3

• AUC（AUC0-t，AUC0-∞）

  Area under the plasma concentration versus time curve

  Day 0 to Day 3

• Tmax

  Time of Cmax

  Day 0 to Day 3

• F

  The rate and extent at which a drug is absorbed into the circulation of the body

  Day 0 to Day 3

Secondary Outcomes (2)

• tl/2

  Day 0 to Day 3

• λz

  Day 0 to Day 3

Study Arms (2)

CuminUP60®,then Curcumin capsules

EXPERIMENTAL

Participants first received CuminUP60® 1600mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 1600mg on the eighth day in a fasting state.

Drug: CuminUP60®; Drug: Curcumin capsules

Curcumin capsules,then CuminUP60®

EXPERIMENTAL

Participants first received curcumin capsules 1600mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP60® 1600mg on the eighth day in a fasting state.

Drug: CuminUP60®; Drug: Curcumin capsules

Interventions

CuminUP60® DRUG

4 capsules, 400 mg / capsule

CuminUP60®,then Curcumin capsules; Curcumin capsules,then CuminUP60®

Curcumin capsules DRUG

4 capsules, 400 mg / capsule

CuminUP60®,then Curcumin capsules; Curcumin capsules,then CuminUP60®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Chenland Nutritionals Inc.: collaborator

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shangdong, 266003, China

Location

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Yu Cao, Master

  Qingdao University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: July 22, 2021
• Study Start: April 9, 2021
• Primary Completion: April 23, 2021
• Study Completion: June 22, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)