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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group1 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug;the remaining 8 subjects,6 received the test drug and 2 received the placebo. |
|
| group2 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. |
|
| group3 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. |
|
| group4 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felbinac Trometamol Injection | Drug | Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance evaluation index | percent of subjects with adverse reactions | up to 48.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | up to 48.5 hours |
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Double-blind
| group5 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. |
|
| group6 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min |
|
| group7 | Experimental | Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min |
|
|
| Placebo | Drug | Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump |
|
|
| up to 48.5 hours |
| t1/2 | The PK parameters of the plasma sample | up to 48.5 hours |
| Vd | The PK parameters of the plasma sample | up to 48.5 hours |
| Mean residence time (MRT) parameter. | The PK parameters of the plasma sample | up to 48.5 hours |
| Ke | The PK parameters of the plasma sample | up to 48.5 hours |
| Area under the plasma concentration versus time curve (AUC0-∞) | The PK parameters of the plasma sample | up to 48.5 hours |
| AUC0-48.5 | The PK parameters of the plasma sample | up to 48.5 hours |
| Ae0-48.5 | The PK parameters of the urine and the stool sample | up to 48.5 hours |
| Fe | The PK parameters of the urine and the stool sample | up to 48.5 hours |
| CLr | The PK parameters of the urine sample | up to 48.5 hours |