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| Name | Class |
|---|---|
| Chenland Nutritionals Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CuminUP30,then Curcumin capsules | Experimental | 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. |
|
| Curcumin capsules,then CuminUP30 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CuminUP30 | Drug | 7 capsules, 500 mg / capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(Peak Plasma Concentration ) | Maximum observed concentration,occurring at Tmax | Day 0 to Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, Master | Contact | 18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao | Qingdao University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center | Recruiting | Qingdao | Shanndong | 266003 | China |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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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)
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| Curcumin capsules | Drug | 5 capsules, 450 mg / capsule |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |