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Completed

NCT Number: NCT05012436

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

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.

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Key information

Conditions

Healthy Volunteer Renal Impairments

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHD1119 75mg

Drug

A single oral dose

Other names: YHD1119 150mg NF

Primary outcomes

  1. Cmax

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  2. AUClast

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Secondary outcomes

  1. AUCinf

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  2. Tmax

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  3. t1/2

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour

  4. CL/F

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

  5. V/F

    Time frame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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