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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St.Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lyrica capsule(Pregabalin 150mg)	Drug: Pregabalin; Pregabalin 300mg a day
Experimental: YHD1119 A(Pregabalin SR 300mg)	Drug: Pregabalin; Pregabalin 300mg a day
Experimental: YHD1119 B(Pregabalin SR 300mg)	Drug: Pregabalin; Pregabalin 300mg a day
Experimental: YHD1119 C(Pregabalin SR 300mg)	Drug: Pregabalin; Pregabalin 300mg a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss		36 hr
AUCtau		36 hr
Safety monitoring	Laboratory findings Adverse event	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
AUClast AUCinfinity Tmax,ss t1/2	36 hour
AUCinfinity	36 hr
Tmax,ss	36 hr
t 1/2	36 hr

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (Estimate): August 22, 2011

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: YCD207