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

NCT05012436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer
  • Renal Impairments

Interventions

DRUG

YHD1119 75mg

A single oral dose

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • SeungHoon Han · The Catholic University of Korea

  • Hyounggyoon Yoo · CHA University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-24
Primary Completion
2022-05-10
Completion
2022-05-10

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012436 on ClinicalTrials.gov