PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects (GLA5PR-102)

A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg and Immediate Release Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site.

To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: Pregabalin 75mg

Detailed Description

Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.

The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon.

As the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release.

At virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release.

This relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
      • Chonbuk National University 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
• ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

• ALT or AST > 1.25(Upper Normal Range)
• Total Bilirubin > 1.5 (Upper Normal Range)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLA5PR GLARS tablet 150mg(mealed); Pregabalin 150mg	Drug: Pregabalin 150mg; GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days; Other Names: GLA5PR GLARS tablet 150mg
ACTIVE_COMPARATOR: Lyrica Capsule 75mg(mealed); Pregabalin 75mg	Drug: Pregabalin 75mg; Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days; Other Names: Lyrica Capsule 75mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax.ss	Pharmacokinetic of Pregabalin	36hrs
AUCtau	Pharmacokinetic of Pregabalin	36hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Pharmacokinetic of Pregabalin	36hrs
CL/F	Pharmacokinetic of Pregabalin	36hrs
Safety Monitoring	Adverse Event, Vital sign, Physical Exam, Laboratory Findings	25 days
AUC0-∞	Pharmacokinetic of Pregabalin	36hrs
Vd/F	Pharmacokinetic parameter of Pregabalin	36hrs
T1/2	Pharmacokinetic parameter of Pregabalin	36hrs

Collaborators and Investigators

• Sponsor: GL Pharm Tech Corporation
• Investigators: Principal Investigator: Min-Gul Kim, MD, Ph.D., Chonbuk National University Hospital

Publications and helpful links

General Publications

• Kim TE, Jeon JY, Gu N, Chang Kwon M, Kim MG. Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2112-2124. doi: 10.1016/j.clinthera.2018.10.017. Epub 2018 Nov 27.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (ESTIMATE): July 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Pregabalin, GLARS
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; 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: GLA5PR-102