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Status unknownNCT05334043CuminUP30Updated Apr 19, 2022

Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects

A Phase 1 interventional study of CuminUP30 and Curcumin capsules in Healthy Adult Subjects, sponsored by The Affiliated Hospital of Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by The Affiliated Hospital of Qingdao University · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 the 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.

02

Conditions studied

  • Healthy Adult Subjects
03

In context

Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • 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.

    Drug: CuminUP30 · Drug: Curcumin capsules

  • 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.

    Drug: CuminUP30 · Drug: Curcumin capsules

Interventions

  • DrugCuminUP30

    7 capsules, 500 mg / capsule

  • DrugCurcumin capsules

    5 capsules, 450 mg / capsule

06

What researchers measure

Primary outcomes

  1. Cmax(Peak Plasma Concentration )

    Maximum observed concentration,occurring at Tmax

    Time frame: Day 0 to Day 3

07

Study locations

1 of 1 sites recruiting
  • Phase I Clinical Research Center
    Qingdao, Shanndong 266003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05334043
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborators
Chenland Nutritionals Inc.
Responsible party
Sponsor
First posted
Apr 19, 2022
Start date
Mar 23, 2022
Primary completion
Apr 7, 2022
Completion
Dec 30, 2022 (estimated)
Last update
Apr 19, 2022

Study contacts

Yu Cao, Master
Contact
caoyu1767@126.com
18661809090
Yu Cao
study director · Qingdao University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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