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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Peripheral Nueropathy Pain

Treatments: Drug: YHD1119; Drug: Lyrica

Study type: Interventional

Funder types: Industry

Identifiers

NCT02783183

YHD1119-103

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

YHD1119

Experimental group

Description:

Pregabalin 300mg

Treatment:

Drug: Lyrica

Drug: YHD1119

Lyrica

Active Comparator group

Description:

Pregabalin 150mg

Treatment:

Drug: Lyrica

Drug: YHD1119