A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

Phase 1

Completed

• Conditions: Peripheral Nueropathy Pain
• Interventions: Drug: YHD1119; Drug: Lyrica

• Registration Number: NCT02783183
• Lead Sponsor: Yuhan Corporation

Brief Summary

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Study Start: 2016-06
• Primary Completion: 2016-08
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• 19~50 years old, healthy male volunteers
• >55Kg(Body weight) and 18.5<BMI<28

Exclusion Criteria

• AST or ALT > 3 * Upper normal range (Lab)
• Total bilirubin > 2.0 mg/dl
• Systolic BP >140 OR <90, Diastolic BP >100 OR <60

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lyrica	YHD1119	Pregabalin 150mg
Lyrica	Lyrica	Pregabalin 150mg
YHD1119	YHD1119	Pregabalin 300mg
YHD1119	Lyrica	Pregabalin 300mg

Primary Outcome Measures

Name	Time	Method
Cmax,ss	0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau	0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary Outcome Measures

Name	Time	Method
AUCinf,ss	0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUClast,ss	0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss	0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours