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

Phase 1

Completed

• Conditions: Healthy Volunteer; Renal Impairments
• Interventions: Drug: YHD1119 75mg

• Registration Number: NCT05012436
• Lead Sponsor: Yuhan Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-24
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHD1119 75mg	YHD1119 75mg	60 \> CLcr (mL/min/1.73m2) \>= 30 Period 1 : YHD1119 75 mg Period 2 : NA
YHD1119 75mg, 150mg NF	YHD1119 75mg	CLcr (mL/min/1.73m2) \>= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF

Primary Outcome Measures

Name	Time	Method
AUClast	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Cmax	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Secondary Outcome Measures

Name	Time	Method
t1/2	0,1,2,3,4,5,6,8,10,12,14,24,48,72hour
CL/F	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Tmax	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
V/F	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
AUCinf	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Trial Locations

Locations (2)

CHA Bundang Medical Center, CHA University; 🇰🇷 Gyeonggi-do, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of