A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Summary

The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.

Timeline

Start

2021-07-24

Primary completion

2022-05-10

Completion

2022-05-10

Publications

• Park M, Choi S, Han S, Shin W, Kim A, Han S, Kim B, Lim Y, Yoo H. Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. Transl Clin Pharmacol. 2023 Dec;31(4):226-237. doi: 10.12793/tcp.2023.31.e20. Epub 2023 Dec 20.

Drugs

Indications