| Trial ID: | L0844 |
| Source ID: | NCT04142970
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| Associated Drug: |
Hsk3486
|
| Title: |
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Impairment
|
| Interventions: |
DRUG: HSK3486
|
| Outcome Measures: |
Primary: Peak concentration (Cmax), Cmax（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients ., -30 minutes before administration until 24 hours post administration on day 1|Area under the concentration-time curve（AUC）, AUC（a measure of the body's exposure to HSK3486）will be compared between normal renal function patients and mild or moderate chronic renal impairment patients ., -30 minutes before administration until 24 hours post administration on day 1 | Secondary: MOAA/S(modified observer's assessment of alert /sedation), -5 minutes before administration until 1 hours post administration on day 1|Bispectral index(BIS), -5 minutes before administration until 1 hours post administration on day 1|Tmax, time to peak observed, -30 minutes before administration until 24 hours post administration on day 1|Total clearance, -30 minutes before administration until 24 hours post administration on day 1|Volume of distribution, -30 minutes before administration until 24 hours post administration on day 1|blood pressure（systolic, diastolic and mean arterial pressure）, safety endpoits, from the screening to 3 days post-dose
|
| Sponsor/Collaborators: |
Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd | Collaborators: The First Affiliated Hospital of Zhengzhou University
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| Gender: |
ALL
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| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2020-01-05
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| Completion Date: |
2020-08-18
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| Results First Posted: |
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| Last Update Posted: |
2020-12-19
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| Locations: |
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, He Nan, 450052, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04142970
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