NCT05427682

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

A Single-center, Non-randomized, Open, Single-dose Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	pyroglutamate rongliflozin capsules	Subjects will receive one 50mg capsule on Day 1

Timeline

• Start date: 2022-04-19
• Primary completion: 2023-03-04
• Completion: 2023-06-02
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: China