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: CmaxTmax 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
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