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A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage

NCT05427682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-05

No results posted yet for this study

Summary

To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

pyroglutamate rongliflozin capsules

Subjects will receive one 50mg capsule on Day 1

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-11-10
Completion
2023-11-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427682 on ClinicalTrials.gov