Healthy Adult SubjectsPhase 1NCT04972045
Bioavailability of Curcumin Capsules in Healthy Adult Subjects
A Phase 1 study testing CuminUP60® and Curcumin capsules in people with Healthy Adult Subjects, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- CuminUP60® and Curcumin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 22 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study
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.
Read the detailed description
Upgraded curcumin capsules(CuminUP60®) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP60® 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.
- Conditions
- Healthy Adult Subjects
- Being tested
- CuminUP60®, Curcumin capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CuminUP60®Drug
4 capsules, 400 mg / capsule
Curcumin capsulesDrug
4 capsules, 400 mg / capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CuminUP60®; Drug: Curcumin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax（Peak Plasma Concentration ）
Maximum observed concentration,occurring at Tmax
Measured: Day 0 to Day 3
AUC（AUC0-t，AUC0-∞）
Area under the plasma concentration versus time curve
Measured: Day 0 to Day 3
Tmax
Time of Cmax
Measured: Day 0 to Day 3
F
The rate and extent at which a drug is absorbed into the circulation of the body
Measured: Day 0 to Day 3
Secondary outcomes (2)
tl/2
Terminal half-life
Measured: Day 0 to Day 3
λz
First Order Terminal Elimination Rate Constant
Measured: Day 0 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start9 Apr 2021
- Primary completion23 Apr 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Chenland Nutritionals Inc.
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Master, Study director, Qingdao University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972045
- Sponsor's protocol ID
- HT-PK-2021-01
- Status last verified
- Aug 2021
- First submitted
- 5 Apr 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Curcumin Capsules in Healthy Adult Subjects: an Open, Randomized, Single-dose, Two-period, Two-sequence Crossover Study
- ClinicalTrials.gov ID
- NCT04972045
- Acronym / sponsor ID
- HT-PK-2021-01
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Chenland Nutritionals Inc.
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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(CuminUP60®) is made from curcumin with a natural extraction content of 95% and excipients through physical process microprocessing, with a curcumin content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the bioavailability by comparing the pharmacokinetics of CuminUP60® 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| CuminUP60®,then Curcumin capsules | Experimental | Drug: CuminUP60®, Drug: Curcumin capsulesParticipants 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. |
| Curcumin capsules,then CuminUP60® | Experimental | Drug: CuminUP60®, Drug: Curcumin capsulesParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CuminUP60®4 capsules, 400 mg / capsule | Drug | CuminUP60®,then Curcumin capsules, Curcumin capsules,then CuminUP60® |
| Curcumin capsules4 capsules, 400 mg / capsule | Drug | CuminUP60®,then Curcumin capsules, Curcumin capsules,then CuminUP60® |
Primary outcome
Cmax（Peak Plasma Concentration ）
Time frame: Day 0 to Day 3
Maximum observed concentration,occurring at Tmax
AUC（AUC0-t，AUC0-∞）
Time frame: Day 0 to Day 3
Area under the plasma concentration versus time curve
Tmax
Time frame: Day 0 to Day 3
Time of Cmax
F
Time frame: Day 0 to Day 3
The rate and extent at which a drug is absorbed into the circulation of the body
2 secondary outcomes
tl/2
Time frame: Day 0 to Day 3
λz
Time frame: Day 0 to Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, Master study director
Qingdao University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CuminUP60® and Curcumin capsules in people with Healthy Adult Subjects, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax（Peak Plasma Concentration ） (time frame: Day 0 to Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.