PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects
NCT ID: NCT01638273
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-02-28
2014-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GLA5PR GLARS tablet 150mg(mealed)
Pregabalin 150mg
Pregabalin 150mg
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
Lyrica Capsule 75mg(mealed)
Pregabalin 75mg
Pregabalin 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pregabalin 150mg
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
Pregabalin 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Exclusion Criteria
* Total Bilirubin \> 1.5 (Upper Normal Range)
20 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GL Pharm Tech Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Min-Gul Kim, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kim TE, Jeon JY, Gu N, Chang Kwon M, Kim MG. Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2112-2124. doi: 10.1016/j.clinthera.2018.10.017. Epub 2018 Nov 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GLA5PR-102
Identifier Type: -
Identifier Source: org_study_id