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

Phase 1CompletedNCT01420913

Yuhan Corporation28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PregabalinDRUG

Pregabalin 300mg a day

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul ST.Mary Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax,ss

Time frame: 36 hr

AUCtau

Time frame: 36 hr

Safety monitoring

Laboratory findings Adverse event

Time frame: 14 days

Secondary Outcomes

AUClast AUCinfinity Tmax,ss t1/2

Time frame: 36 hour

AUCinfinity

Time frame: 36 hr

Tmax,ss

Time frame: 36 hr

t 1/2

Time frame: 36 hr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.