| Trial ID: | L5979 |
| Source ID: | NCT03159832
|
| Associated Drug: |
Shr3824
|
| Title: |
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency,Type 2 Diabetes
|
| Interventions: |
DRUG: SHR3824
|
| Outcome Measures: |
Primary: The area under the plasma concentration-time curve (AUC) of SHR3824, AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients, 72 hours after dosing|The maximum plasma concentration (Cmax) of SHR3824, Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients, 72 hours after dosing | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability, The number of volunteers with adverse events as a measure of safety and tolerability, 72 hours after dosing
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06
|
| Completion Date: |
2017-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-05-19
|
| Locations: |
Chinese people's liberation army general hospital of Chengdu military area, Chengdu, Sichuan, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03159832
|
