Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01420913

YCD207

Details and patient eligibility

About

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

Enrollment: 28 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20~45 years old, healthy adult male subject
• >55 Kg(Body weight) and < ideal body weight ± 20%

Exclusion criteria

• AST or ALT > 1.25 * Upper normal range (Lab)
• Total bilirubin > 1.5 * Upper normal range
• Systolic BP >140 OR <100, Diastolic BP >90 OR <65

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Lyrica capsule(Pregabalin 150mg)

Active Comparator group

Treatment:

Drug: Pregabalin

YHD1119 A(Pregabalin SR 300mg)

Experimental group

Treatment:

Drug: Pregabalin

YHD1119 B(Pregabalin SR 300mg)

Experimental group

Treatment:

Drug: Pregabalin

YHD1119 C(Pregabalin SR 300mg)

Experimental group

Treatment:

Drug: Pregabalin