A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
NCT05374343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-04-30
Summary
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
Conditions
Interventions
- DRUG
-
pyroglutamate rongliflozin capsules
Subjects will receive one 50mg capsule orally (by mouth) on Day 1
Sponsors & Collaborators
-
Sunshine Lake Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Ping Feng, Doctor · West China Hospital
-
Zhenmei An, Master · West China Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-05
- Primary Completion
- 2023-08-24
- Completion
- 2023-08-24
Countries
- China
Study Locations
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