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The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.
The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25mg | Experimental | Tablets, Oral, 25mg, single dose |
|
| 50mg | Experimental | Tablets, Oral, 50mg, single dose |
|
| 100mg | Experimental | Tablets, Oral, 100mg, single dose |
|
| 200mg | Experimental | Tablets, Oral, 200mg, single dose |
|
| 400mg | Experimental | Tablets, Oral, 400mg, single dose |
|
| 800mg | Experimental | Tablets, Oral, 800mg, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25mg | Drug | SYHA1402 25mg or Placebo 25mg |
| |
| 50mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change of systolic blood pressure and diastolic blood pressure | To assess the change of blood pressure after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours |
| Change of heart rate | To assess the change of heart rate after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours |
| Change of pulse | To assess pulse after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours |
| Change of body temperature | To assess the change of body temperature after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours |
| Change of 12-lead ECG | To assess the change of 12-lead ECG (PR,QRS,QT,QTc) after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours |
| Change of physical examination | To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402 | 24, 48, 72 hours |
| Change of blood biochemistry | To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402 | 24, 48, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Plasma peak concentration (Cmax) after administration of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |
| Peak time (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of the People's Liberation Army | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37093466 | Derived | Liang B, Wang J, Zhang G, Wang R, Cai Y. Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects. Neurol Ther. 2023 Jun;12(3):947-959. doi: 10.1007/s40120-023-00480-x. Epub 2023 Apr 24. |
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| ID | Term |
|---|---|
| C000615291 | Magnesium-25 |
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| Drug |
SYHA1402 50mg or Placebo 50mg |
|
| 100mg | Drug | SYHA1402 100mg or Placebo 100mg |
|
| 200mg | Drug | SYHA1402 200mg or Placebo 200mg |
|
| 400mg | Drug | SYHA1402 400mg or Placebo 400mg |
|
| 800mg | Drug | SYHA1402 800mg or Placebo 800mg |
|
| Chagne of blood routine | To assess the change of blood routine after administration of SYHA1402 | 24, 48, 72 hours |
| Change of urinary routine | To assess the change of urinary routine after administration of SYHA1402 | 24, 48, 72 hours |
Plasma peak time (Tmax) after administration of SYHA1402
| 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |
| Area under the plasma concentration-time curve (AUC0-72h) | The area under the plasma concentration-time curve of SYHA1402 after administration are calculated. | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |
| Half time (t1/2) | The half time of SYHA1402 after administration are calculated. | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |
| Apparent clearance (CL/F) | To assess the apparent clearance (CL/F) after administration of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |
| Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 | To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |