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The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSP1273 Sequence 1 | Experimental | Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period,then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period. |
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| ZSP1273 Sequence 2 | Experimental | Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period,then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1273 tablet | Drug | Participants receive ZSP1273 tablet orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 |
| Area under the concentration-time curve from time zero to infinity (AUCinf) | The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 |
| Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast) | The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared. | Day 1 to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Hospital of Chinese Medicine | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
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| zsp1273 granules | Drug | Participants receive ZSP1273 granules orally. |
|