NCT06883656

The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency

The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency and Matched Healthy Volunteers with Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Renal Insuficiency

Interventions

Type	Name	Description
DRUG	SAL067	Fasting oral test drug 12mg

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: China