A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers
1 other identifier
interventional
40
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 P50-P75 for phase_1 healthy
Started Oct 2014
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, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
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
Same day
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 (4)
GLA5PR GLARS-NF1 tablet 150mg
EXPERIMENTALGLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day, after meal)
GLA5PR GLARS-NF1 tablet 300mg
EXPERIMENTALGLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day, after meal)
GLA5PR GLARS-NF1 tablet 450mg
EXPERIMENTALGLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)
GLA5PR GLARS-NF1 tablet 600mg
EXPERIMENTALGLA5PR GLARS-NF1 tablet 600mg/day(Pregabalin 300mg, 2 tablets 1 times a day, after meal)
Interventions
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Eligibility Criteria
You may qualify if:
- \~45 years old, Healthy Adult Male Subject
- \~30.5kg/m2(BMI) and ≥ 40kg(Body Weight)
You may not qualify if:
- SBP ≥ 140mmHg or DBP ≥ 90mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Shin KH, Jeon JY, Jang K, Kim TE, Kim MG. Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study. Drug Des Devel Ther. 2018 Oct 11;12:3449-3457. doi: 10.2147/DDDT.S167668. eCollection 2018.
PMID: 30349198DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 30, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12