HealthyPhase 1GLA5PR-101NCT01635751
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
A Phase 1 study testing Pregabalin in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20~45 years old, Healthy Adult Male Subject
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Who cannot join
- ALT or AST > 1.25(Upper Normal Range)
- Total Bilirubin > 1.5 (Upper Normal Range)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St.Mary's Hospital
Seochogu, Seoul, 137-701
About this study
Official title: 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.
Read more
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)".
Read the 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.
- Conditions
- Healthy
- Being tested
- Pregabalin
- Keywords
- Pregabalin, GLARS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
PregabalinDrug
GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
PregabalinDrug
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
| Study group | Role | What they receive |
|---|---|---|
| GLA5PR GLARS tablet 150mg(fasted) | Experimental | Not described Receives: Drug: Pregabalin |
| GLA5PR GLARS tablet 150mg(after high fat meal) | Experimental | Not described Receives: Drug: Pregabalin |
| Lyrica Capsule 75mg(fasted) | Active comparator | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic of Pregabalin
Measured: 36hrs
Tmax
Pharmacokinetic of Pregabalin
Measured: 36hrs
AUC0-36h
Pharmacokinetic of Pregabalin
Measured: 36hrs
AUC0-∞
Pharmacokinetic of Pregabalin
Measured: 36hrs
CL/F
Pharmacokinetic of Pregabalin
Measured: 36hrs
Vd/F
Pharmacokinetic of Pregabalin
Measured: 36hrs
T1/2
Pharmacokinetic of Pregabalin
Measured: 36hrs
Secondary outcomes (1)
Safety Monitoring
Adverse Event, Vital sign, 12-lead ECG, Laboratory test
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-seok Yim, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635751
- Sponsor's protocol ID
- GLA5PR-101
- Acronym
- GLA5PR-101
- Status last verified
- Jan 2013
- First submitted
- 4 Jul 2012
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01635751
- Acronym / sponsor ID
- GLA5PR-101 / GLA5PR-101
- Conditions
- Healthy
- Keywords
- Pregabalin, GLARS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)".
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLA5PR GLARS tablet 150mg(fasted) | Experimental | Drug: Pregabalin |
| GLA5PR GLARS tablet 150mg(after high fat meal) | Experimental | Drug: Pregabalin |
| Lyrica Capsule 75mg(fasted) | Active comparator | Drug: Pregabalin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20~45 years old, Healthy Adult Male Subject
- ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%
Key exclusion criteria (2 listed)
- ALT or AST > 1.25(Upper Normal Range)
- Total Bilirubin > 1.5 (Upper Normal Range)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinGLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted) | Drug | GLA5PR GLARS tablet 150mg(fasted) |
| PregabalinGLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal) | Drug | GLA5PR GLARS tablet 150mg(after high fat meal) |
| PregabalinLyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted) | Drug | Lyrica Capsule 75mg(fasted) |
Primary outcome
Cmax
Time frame: 36hrs
Pharmacokinetic of Pregabalin
Tmax
Time frame: 36hrs
Pharmacokinetic of Pregabalin
AUC0-36h
Time frame: 36hrs
Pharmacokinetic of Pregabalin
AUC0-∞
Time frame: 36hrs
Pharmacokinetic of Pregabalin
CL/F
Time frame: 36hrs
Pharmacokinetic of Pregabalin
Vd/F
Time frame: 36hrs
Pharmacokinetic of Pregabalin
T1/2
Time frame: 36hrs
Pharmacokinetic of Pregabalin
1 secondary outcome
Safety Monitoring
Time frame: 23 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-seok Yim principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregabalin in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 36hrs). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.