| Trial ID: | L2811 |
| Source ID: | NCT06132204
|
| Associated Drug: |
Hrs-7535 Tablets
|
| Title: |
Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS-7535 Tablets
|
| Outcome Measures: |
Primary: PK parameters of HRS-7535: Cmax, 0 hour to 48 hour after administration|PK parameters of HRS-7535: AUC0-t, 0 hour to 48 hour after administration|PK parameters of HRS-7535: AUC0-inf, 0 hour to Infinity hour after administration | Secondary: PK parameters of HRS-7535: Tmax, 0 hour to 48 hour after administration|PK parameters of HRS-7535: t1/2, 0 hour to 48 hour after administration|PK parameters of HRS-7535: CL/F, 0 hour to 48 hour after administration|PK parameters of HRS-7535: Vz/F, 0 hour to 48 hour after administration|Adverse events, from ICF signing date to day 7 （+3）after administration
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-21
|
| Completion Date: |
2024-03-13
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-15
|
| Locations: |
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06132204
|
