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This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1893 test formulation group | Experimental |
| |
| HRS-1893 reference formulation group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation of HRS-1893 tablet | Drug | Test formulation of HRS-1893 tablet, oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax). | Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Area under the plasma concentration - time curve from Time 0 to the last quantifiable time point (AUC0-t). | Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Area under the plasma concentration - time curve from Time 0 to infinity (AUC0-∞). | Primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration (Tmax). | Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Elimination half-life (t1/2). | Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzheng Xiong | Contact | +86-0518-82342973 | wenzheng.xiong.wx10@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This study is a single-center, randomized, open-label, crossover trial designed to evaluate the bioequivalence of two formulations of HRS-1893 tablets.
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| Reference formulation of HRS-1893 tablet | Drug | Reference formulation of HRS-1893 tablet, oral. |
|
| From Day 1 to Day 17. |
| Apparent clearance (CL/F). | Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Apparent volume of distribution (Vz/F). | Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 17. |
| Incidence and severity of any adverse events (AEs). | Safety and tolerability of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 21 ± 2. |
| 12-Lead Electrocardiogram (ECG) QT Interval. | Safety and tolerability of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 21 ± 2. |
| Transthoracic echocardiogram (TTE) results. | Safety and tolerability of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 21 ± 2. |
| Vital signs results - blood pressure. | Safety and tolerability of different HRS-1893 formulations in healthy subjects. | From Day 1 to Day 21 ± 2. |