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

Yuhan Corporation16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Renal Impairments

Interventions

YHD1119 75mgDRUG

A single oral dose

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 19\~75 years old, healthy volunteers and renal impairments * eGFR \>= 60mL/min/1.73m2 * 60 mL/min/1.73m2 \> eGFR \>= 30mL/min/1.73m2 * written informed consent Exclusion Criteria: * AST or ALT \> 1.5 \* Upper normal range * Total bilirubin \> 1.5 \* Upper normal range * Blood CPK \> 1.5 \* Upper normal range * Total Cholesterol \>1.5 \* Upper normal range * Woman who is pregnant or lactating * Patients who are difficult to participate in cinical trials judged by Investigators * have participated in other clinical trials within 180 days before IP intake

Locations (2)

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea