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UnknownNCT05374343

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment

A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Sunshine Lake Pharma Co., Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGpyroglutamate rongliflozin capsulesSubjects will receive one 50mg capsule orally (by mouth) on Day 1

Timeline

Start date
2022-05-05
Primary completion
2023-11-15
Completion
2024-02-13
First posted
2022-05-16
Last updated
2022-05-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05374343. Inclusion in this directory is not an endorsement.

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Imp (NCT05374343) · Clinical Trials Directory