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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-24

Study Completion Date

2022-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

NCT04952506

Chronic Renal Failure

COMPLETED PHASE1

Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance

NCT01237899

Chronic Kidney Disease

COMPLETED PHASE1

Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment

NCT06671444

Insomnia Renal Impairment

ACTIVE_NOT_RECRUITING PHASE1

Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

NCT03864458

Hyperphosphatemia

COMPLETED PHASE2

PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function

NCT04656795

Renal Impairment Normal Renal Function

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer Renal Impairments

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

YHD1119 75mg, 150mg NF

CLcr (mL/min/1.73m2) \>= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF

Group Type EXPERIMENTAL

YHD1119 75mg

Intervention Type DRUG

A single oral dose

YHD1119 75mg

60 \> CLcr (mL/min/1.73m2) \>= 30 Period 1 : YHD1119 75 mg Period 2 : NA

Group Type EXPERIMENTAL

YHD1119 75mg

Intervention Type DRUG

A single oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

YHD1119 75mg

A single oral dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

YHD1119 150mg NF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes