| Trial ID: | L2114 |
| Source ID: | NCT05427682
|
| Associated Drug: |
Pyroglutamate Rongliflozin Capsules
|
| Title: |
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| 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 liver function., 0 hour（pre-dose） to 96 hours after administration | Secondary: Incidence of Adverse Events [safety], To evaluate the safety of pyroglutamate rongliflozin capsules in subjects with mild to moderate liver damage and healthy subjects, 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: |
2022-04-19
|
| Completion Date: |
2023-06-02
|
| Results First Posted: |
|
| Last Update Posted: |
2022-06-22
|
| Locations: |
West China Hospital of Sichuan University, Chengdu, Sichuan, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05427682
|
