- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635751
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
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)".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.
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 malabsorption 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Seoul
-
Seochogu, Seoul, Korea, Republic of, 137-701
- The Catholic University of Korea, Seoul St.Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20~45 years old, Healthy Adult Male Subject
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Exclusion Criteria:
- ALT or AST > 1.25(Upper Normal Range)
- Total Bilirubin > 1.5 (Upper Normal Range)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLA5PR GLARS tablet 150mg(fasted)
|
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
|
Experimental: GLA5PR GLARS tablet 150mg(after high fat meal)
|
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
|
Active Comparator: Lyrica Capsule 75mg(fasted)
|
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
Tmax
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
CL/F
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
Vd/F
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
AUC0-∞
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
AUC0-36h
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
T1/2
Time Frame: 36hrs
|
Pharmacokinetic of Pregabalin
|
36hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Monitoring
Time Frame: 23 days
|
Adverse Event, Vital sign, 12-lead ECG, Laboratory test
|
23 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dong-seok Yim, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- GLA5PR-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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