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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-TTRCC-13003277 | Other Identifier | Chinese Clinical Trial Registry |
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| Name | Class |
|---|---|
| West China Second University Hospital | OTHER |
| Sichuan University | OTHER |
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24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized, crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1 as detection indicators. Establish the "blood drug concentration-time " curve, compare the bioequivalence of the main effective ingredients of the two preparations during the absorption process in human.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sanchi-Tongshu Capsule (Enteric coated pellets) | Experimental | Sanchi-Tongshu Capsule (Enteric coated pellets) is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.35g/capsule, containing 100mg of panaxatriol saponins (PTS). |
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| Sanchi-Tongshu Capsule | Active Comparator | Sanchi-Tongshu Capsule is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.2g/capsule, containing 100mg of panaxatriol saponins (PTS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sanchi-Tongshu Capsule (Enteric coated pellets) | Drug | Take 0.7g (2 Capsules) of test preparation orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h) | Up to 33 hours post dose | |
| Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞) | Up to 33 hours post dose | |
| Maximum observed concentration (Cmax ) | Up to 33 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xihong Li, MD | West China Second University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Chengdu | Sichuan | 610000 | China |
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| Sanchi-Tongshu Capsule | Drug | Take 0.4g (2 Capsules) of reference preparation orally. |
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