NCT04126538

Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics

Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics of Single Dose

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and pharmacokinetic characteristics of pirfenidone capsules in chronic kidney disease G2 and G3a patients, and to provide a basis for the phase II clinical trial program

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	pirfenidone capsule	In the patient group, pirfenidone capsule was taken orally once for 400mg
DRUG	pirfenidone capsule	Healthy subjects took pirfenidone capsule 400mg once orally

Timeline

• Start date: 2019-08-27
• Primary completion: 2021-11-25
• Completion: 2022-06-30
• First posted: 2019-10-15
• Last updated: 2022-03-29

Locations

1 site across 1 country: China