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

GL Pharm Tech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pregabalin 150mg; Drug: Pregabalin 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327000

GLA5PR-104

Details and patient eligibility

About

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)".

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

GLA5PR GLARS-NF1 tablet 150mg

Experimental group

Description:

GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day, after meal)

Treatment:

Drug: Pregabalin 150mg

GLA5PR GLARS-NF1 tablet 300mg

Experimental group

Description:

GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day, after meal)

Treatment:

Drug: Pregabalin 300mg

GLA5PR GLARS-NF1 tablet 450mg

Experimental group

Description:

GLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)

Treatment:

Drug: Pregabalin 300mg

Drug: Pregabalin 150mg

GLA5PR GLARS-NF1 tablet 600mg

Experimental group

Description:

GLA5PR GLARS-NF1 tablet 600mg/day(Pregabalin 300mg, 2 tablets 1 times a day, after meal)

Treatment:

Drug: Pregabalin 300mg