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

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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