| Trial ID: | L4745 |
| Source ID: | NCT05374343
|
| Associated Drug: |
Pyroglutamate Rongliflozin Capsules
|
| Title: |
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: pyroglutamate rongliflozin capsules
|
| Outcome Measures: |
Primary: Plasma concentrations of rongliflozin, Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function., 0 hour（pre-dose） to 96 hours after administration | Secondary: Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function, Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of rongliflozin will be used to evaluate the pharmacodynamics of rongliflozin (ie, how the drug affects the body) in varying degrees of kidney function., Day -1 (Baseline) to Day 5
|
| Sponsor/Collaborators: |
Sponsor: Sunshine Lake Pharma Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-05
|
| Completion Date: |
2024-02-13
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-16
|
| Locations: |
Ping Feng, Chendu, Sichuan, 610041, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05374343
|
