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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer; Renal Impairments

Treatments: Drug: YHD1119 75mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05012436

YHD1119-107

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

YHD1119 75mg, 150mg NF

Experimental group

Description:

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

Treatment:

Drug: YHD1119 75mg

YHD1119 75mg

Experimental group

Description:

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

Treatment:

Drug: YHD1119 75mg