A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects
A Randomized, Open, Single-dose, 3-treatment, 3-period, 6-sequence Crossover Study in Healthy Male Subjects to Evaluate the Pharmacokinetics of GLA5PR GLARS-NF1 Tablet 150mg and LYRICA® Capsule 75mg
1 other identifier
interventional
30
0 countries
N/A
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 Oct 2013
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedDecember 30, 2014
December 1, 2014
1 month
December 10, 2014
December 23, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
Pharmacokinetic of Pregabalin
36hrs
Cmax
Pharmacokinetic of Pregabalin
36hrs
Secondary Outcomes (5)
AUCinf
36hrs
Tmax
36hrs
t1/2
36hrs
CL/F
36hrs
Vd/F
36hrs
Study Arms (3)
GLA5PR GLARS-NF1 tab.150mg(fasted)
EXPERIMENTALGLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)
GLA5PR GLARS-NF1 tab.150mg(after high fat meal)
EXPERIMENTALGLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day)
Lyrica Capsule 75mg(after high fat meal)
ACTIVE COMPARATORLyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
Interventions
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
Eligibility Criteria
You may qualify if:
- \~45 years old, Healthy Adult Male Subject
- \~30.5kg/m2(BMI) and ≥ 45kg
You may not qualify if:
- SBP ≥ 140mmHg or DBP ≥ 90mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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 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
December 10, 2014
First Posted
December 30, 2014
Study Start
October 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 30, 2014
Record last verified: 2014-12