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Main objective:
Through blood drug concentration testing, evaluate the post-meal pharmacokinetic characteristics of the curcumin product compared to similar products, and assess the differences in body exposure between the self-developed product and the control product in healthy trial participants.
Secondary objective:
Observe the safety of the self-developed product and the control product in healthy trial participants.
Study population:
Healthy male individuals or non-pregnant non-lactating females
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano Curcumin Capsules | Experimental | Test Group |
|
| Curcumin Capsules | Active Comparator | Reference Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | In the first cycle, take 4 capsules of the self-developed product (T, Nano Curcumin Capsules) (125 mg per capsule), in the second cycle take 2 capsules of the control product (R, Curcumin Capsules) (250 mg per capsule), take with 240 mL of water, and the cleansing period is 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) 0-t | plasma concentration-time curve from zero to the time of the last measurable time point t | 2 weeks |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 2 weeks |
| Area under the plasma concentration versus time curve (AUC)0-∞ | area under the plasma concentration-time curve from zero to infinity | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiyue Liu | Contact | 86-15952401034 | qiyue.liu@cxpharma.com | |
| Lu Ye | Contact | 86-13950049562 | lbe_yl@accube.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 55, Zhenhai Road | Xiamen | Fujian | 361022 | China |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| C000730654 | nanocurcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
| Nanocurcumin | Dietary Supplement | In the first cycle, take 2 capsules (250mg each) of the control product (R, Curcumin Capsules). In the second cycle, take 4 capsules (125mg each) of the self-developed product (T, Nano Curcumin Capsules). Take with 240 mL of water and the cleansing period is 7 days. |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |