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This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B.
Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles.
Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Each subject receive the same dose(X1mg) of LPM3480392 in 15minutes in the first cycle, 5 minutes in the second cycle, and 2 minutes in the third cycle . |
|
| Part B | Experimental | Each subject receive LPM3480392 X2mg in the first cycle and LPM3480392 X3mg in the second cycle . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3480392 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidents of AE (including SAE) | including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG | from baseline to day7 of second or third cycle(each cycle is 4 days) |
| DEQ scores | Drug effect questionnaire | from baseline to day2 of second or third cycle(each cycle is 4 days) |
| OWS scores | Opiate Withdrawal Scale | from baseline to day7 of second or third cycle(each cycle is 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Pharmacokinetic index | baseline and within 24 hours after administration |
| AUC0-∞ | Pharmacokinetic index | baseline and within 24 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hosipital zhejiang university school of medicine | Hangzhou | Zhejiang | 310000 | China |
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| Cmax | Pharmacokinetic index | baseline and within 24hours after administration |
| Tmax | Pharmacokinetic index | baseline and within 24 hours after administration |
| T1/2 | Pharmacokinetic index | baseline and within 24 hours after administration |
| CL | Pharmacokinetic index | baseline and within24 hours after administration |
| Vd | Pharmacokinetic index | baseline and within 24 hours after administration |
| MRT | Pharmacokinetic index | baseline and within 24 hours after administration |
| λz | Pharmacokinetic index | baseline and within 24 hours after administration |
| Cold Pain Test | Pharmacodynamic index | baseline and within 8 hours after administration |
| Pupillometry | Pharmacodynamic index | baseline and within 8 hours after administration |