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A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects | Clinical Trials | Clareo Health

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

A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

NCT05012436•Yuhan Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

July 24, 2021

Primary Completion Date

May 10, 2022

Completion Date

May 10, 2022

Last Updated

June 30, 2022

Enrollment

ACTUAL participants

Conditions

Healthy VolunteerRenal Impairments

Interventions

YHD1119 75mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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