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A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects

Information source: GL Pharm Tech Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GL Pharm Tech Corporation

Official(s) and/or principal investigator(s):
Dong-seok Yim, Principal Investigator, Affiliation: The Catholic University of Korea

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 once-a-day formulation which is made by GL Pharm Tech corporation. 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)".

Clinical Details

Official title: A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Cmax

Tmax

AUC0-36h

AUC0-∞

CL/F

Vd/F

T1/2

Secondary outcome: Safety Monitoring

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 malabsorption 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.

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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)

Locations and Contacts

The Catholic University of Korea, Seoul St.Mary's Hospital, Seochogu, Seoul 137-701, Korea, Republic of
Additional Information

Starting date: October 2012
Last updated: January 25, 2013

Page last updated: August 23, 2015

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