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The purpose of this study was to compare the hydronidone capsules (specification: 30 mg/particle, test preparation) developed by Shanghai Ruixing Gene Technology corporation with Self reference preparation hydronidone capsule (specification: 15 mg/capsule) Differences in the extent and rate of absorption of healthy male subjects in Fasting state in China. Through the main pharmacokinetic parameters and relative bioavailability, whether the two are bioequivalent, and provide a basis for the registration of the test preparation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | Hydronidone capsules (Specification: 30 mg / capsule) |
|
| Control group | Placebo Comparator | Hydronidone capsules (Specification: 15 mg / capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydronidone Capsule(Specification: 30 mg / grain) | Drug | Test group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | up to 12 weeks | |
| AUC | up to 12 weeks | |
| Tmax | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| λz | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D002523 | Edible Grain |
| ID | Term |
|---|---|
| D018556 | Crops, Agricultural |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Hydronidone Capsule(Specification: 15 mg / grain) |
| Drug |
Control group |
|
| D012639 |
| Seeds |
| D019602 | Food and Beverages |