PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects
GLA5PR-102
A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg and Immediate Release Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects
1 other identifier
interventional
24
1 country
1
Brief 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 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)".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Feb 2014
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 13, 2014
November 1, 2014
5 months
July 9, 2012
November 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax.ss
Pharmacokinetic of Pregabalin
36hrs
AUCtau
Pharmacokinetic of Pregabalin
36hrs
Secondary Outcomes (6)
Safety Monitoring
25 days
Tmax
36hrs
AUC0-∞
36hrs
CL/F
36hrs
Vd/F
36hrs
- +1 more secondary outcomes
Study Arms (2)
GLA5PR GLARS tablet 150mg(mealed)
EXPERIMENTALPregabalin 150mg
Lyrica Capsule 75mg(mealed)
ACTIVE COMPARATORPregabalin 75mg
Interventions
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
Eligibility Criteria
You may qualify if:
- \~45 years old, Healthy Adult Male Subject
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
You may not qualify if:
- ALT or AST \> 1.25(Upper Normal Range)
- Total Bilirubin \> 1.5 (Upper Normal Range)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Related Publications (1)
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.
PMID: 30497798DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min-Gul Kim, MD, Ph.D.
Chonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
November 1, 2014
Last Updated
November 13, 2014
Record last verified: 2014-11