A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin 300mg; Drug: Pregabalin 150mg

• Registration Number: NCT02327000
• Lead Sponsor: GL Pharm Tech Corporation

Brief Summary

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)".

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 Timeline

• Study Start: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-23
• Last Update Submitted: 2014-12-23
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• 19~45 years old, Healthy Adult Male Subject
• 17.5~30.5kg/m2(BMI) and ≥ 40kg(Body Weight)

Exclusion Criteria

• SBP ≥ 140mmHg or DBP ≥ 90mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLA5PR GLARS-NF1 tablet 300mg	Pregabalin 300mg	GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day, after meal)
GLA5PR GLARS-NF1 tablet 450mg	Pregabalin 150mg	GLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)
GLA5PR GLARS-NF1 tablet 450mg	Pregabalin 300mg	GLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)
GLA5PR GLARS-NF1 tablet 150mg	Pregabalin 150mg	GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day, after meal)
GLA5PR GLARS-NF1 tablet 600mg	Pregabalin 300mg	GLA5PR GLARS-NF1 tablet 600mg/day(Pregabalin 300mg, 2 tablets 1 times a day, after meal)

Primary Outcome Measures

Name	Time	Method
AUClast	36hrs	Pharmacokinetic of Pregabalin
Cmax	36hrs	Pharmacokinetic of Pregabalin

Secondary Outcome Measures

Name	Time	Method
t1/2	36hrs	Pharmacokinetic of Pregabalin
CL/F	36hrs	Pharmacokinetic of Pregabalin
AUCinf	36hrs	Pharmacokinetic of Pregabalin
Tmax	36hrs	Pharmacokinetic of Pregabalin
Vd/F	36hrs	Pharmacokinetic of Pregabalin