- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05334043
Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects (CuminUP30)
Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
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%. CuminUP30 capsules are 500 mg/ capsules and ordinary curcumin capsules are 450 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP30 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yu Cao, Master
- Phone Number: 18661809090
- Email: caoyu1767@126.com
Study Locations
-
-
Shanndong
-
Qingdao, Shanndong, China, 266003
- Recruiting
- Phase I Clinical Research Center
-
Contact:
- Yu Doctor Cao
- Phone Number: 86 18661809090
- Email: caoyu1767@126.com
-
Contact:
- Chenjing Wang
- Phone Number: +8617853298769
- Email: wangchenjing1117@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CuminUP30,then Curcumin capsules
Participants first received CuminUP30 3500mg on the first day in a fasting state.After a washout period of 7days,they then received curcumin capsules 2250mg on the eighth day in a fasting state.
|
7 capsules, 500 mg / capsule
5 capsules, 450 mg / capsule
|
Experimental: Curcumin capsules,then CuminUP30
Participants first received curcumin capsules 2250mg on the first day in a fasting state.After a washout period of 7days,they then received CuminUP30 3500mg on the eighth day in a fasting state.
|
7 capsules, 500 mg / capsule
5 capsules, 450 mg / capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax(Peak Plasma Concentration )
Time Frame: Day 0 to Day 3
|
Maximum observed concentration,occurring at Tmax
|
Day 0 to Day 3
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Yu Cao, Qingdao University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- HT-PK-2021-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adult Subjects
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
-
China Resources Biopharmaceutical Co., LtdPeking University Third HospitalRecruiting
-
Auzone Biological Technology Pty LtdCompleted
-
Mitsubishi Tanabe Pharma CorporationCompletedHealthy Adult SubjectsJapan
-
Alvotech Swiss AGIqvia Pty LtdCompletedHealthy Adult SubjectsNew Zealand, United Kingdom
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Connect Biopharma Australia Pty LtdCompletedHealthy Adult SubjectsAustralia
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Adult SubjectsChina