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To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R |
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| Sequence 2 | Experimental | Period 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1 |
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| Sequence 3 | Experimental | Period 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2 |
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| Sequence 4 | Experimental | Period 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R |
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| Sequence 5 | Experimental | Period 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2 |
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| Sequence 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR091506 tablet | Drug | In each period under fed conditions, subjects received oral administration of either HR091506 tablet(T1), HR091506 tablet(T2), or HR091506 tablet(R). |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum plasma concentration. Blood samples will be collected. | From 0 hour predose up to 36 hours postdose | |
| AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected. | From 0 hour predose up to 36 hours postdose | |
| AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected. | From 0 hour predose up to 36 hours postdose | |
| Tmax: Observed time to reach Cmax. Blood samples will be collected. | From 0 hour predose up to 36 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent AEs (TEAEs) | From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cangzhou Central Hospital | Cangzhou | Hebei | 061000 | China |
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Period 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1
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