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NCT05012436 Clinical Trial

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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05012436
Other study ID # YHD1119-107
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 24, 2021
Est. completion date May 10, 2022

Study information
Verified date June 2022
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 10, 2022
Est. primary completion date May 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• YHD1119 75mg
A single oral dose

Locations
Country Name City State
Korea, Republic of CHA Bundang Medical Center, CHA University Gyeonggi-do
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Primary AUClast 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Secondary AUCinf 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Secondary Tmax 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Secondary t1/2 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour
Secondary CL/F 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Secondary V/F 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
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