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
GLA5PR-101
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
1 other identifier
interventional
30
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 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)".
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 Oct 2012
Shorter than P25 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 4, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 28, 2013
January 1, 2013
1 month
July 4, 2012
January 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Cmax
Pharmacokinetic of Pregabalin
36hrs
Tmax
Pharmacokinetic of Pregabalin
36hrs
AUC0-36h
Pharmacokinetic of Pregabalin
36hrs
AUC0-∞
Pharmacokinetic of Pregabalin
36hrs
CL/F
Pharmacokinetic of Pregabalin
36hrs
Vd/F
Pharmacokinetic of Pregabalin
36hrs
T1/2
Pharmacokinetic of Pregabalin
36hrs
Secondary Outcomes (1)
Safety Monitoring
23 days
Study Arms (3)
GLA5PR GLARS tablet 150mg(fasted)
EXPERIMENTALGLA5PR GLARS tablet 150mg(after high fat meal)
EXPERIMENTALLyrica Capsule 75mg(fasted)
ACTIVE COMPARATORInterventions
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
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)
The Catholic University of Korea, Seoul St.Mary's Hospital
Seochogu, Seoul, 137-701, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong-seok Yim
The Catholic University of Korea
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 4, 2012
First Posted
July 10, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
January 28, 2013
Record last verified: 2013-01