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

NCT ID: NCT02327000

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GLA5PR GLARS-NF1 tablet 150mg

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

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

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

GLA5PR GLARS-NF1 tablet 300mg

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

Group Type EXPERIMENTAL

Pregabalin 300mg

Intervention Type DRUG

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

GLA5PR GLARS-NF1 tablet 450mg

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

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

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

Pregabalin 300mg

Intervention Type DRUG

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

GLA5PR GLARS-NF1 tablet 600mg

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

Group Type EXPERIMENTAL

Pregabalin 300mg

Intervention Type DRUG

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

Interventions

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Pregabalin 150mg

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

Intervention Type DRUG

Pregabalin 300mg

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

Intervention Type DRUG

Other Intervention Names

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GLA5PR GLARS-NF1 tablet 150mg GLA5PR GLARS-NF1 tablet 300mg

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GL Pharm Tech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Shin KH, Jeon JY, Jang K, Kim TE, Kim MG. Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study. Drug Des Devel Ther. 2018 Oct 11;12:3449-3457. doi: 10.2147/DDDT.S167668. eCollection 2018.

Reference Type DERIVED
PMID: 30349198 (View on PubMed)

Other Identifiers

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GLA5PR-104

Identifier Type: -

Identifier Source: org_study_id