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This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test preparation |
| ||
| reference preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aximus capsules(test) | Other | Aximus capsules test preparation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Excretion volume | drug concentration in urine | Within 12 hours after taking medication |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Ting Li, Master | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study | Wenzhou | China |
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| Aximus capsules(reference) |
| Drug |
Aximus capsules reference preparation |
|