A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects

Summary

To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects

Timeline

Start

2022-03-31

Primary completion

2022-10-25

Completion

2022-10-25

Publications

• Fu P, Song Y, Hu C, Yong X, Yu Y, Chen Y, Wang Y, Zhu X, Wang Z, Wang Y, Juan J, Chen Y, Miao J. A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment. Clin Pharmacol Drug Dev. 2025 Jun;14(6):479-486. doi: 10.1002/cpdd.1536. Epub 2025 Apr 21.

Drugs

Indications