HealthyPhase 1NCT02326987
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 Phase 1 study testing Pregabalin 150mg and Pregabalin 75mg in people with Healthy, run by GL Pharm Tech Corporation.
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 Formulation which is made by GL Pharm Tech. 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 150mg and Pregabalin 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2013
- 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
- 17.5~30.5kg/m2(BMI) and ≥ 45kg
Who cannot join
- SBP ≥ 140mmHg or DBP ≥ 90mmHg
About this study
Official title: 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
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.
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 mal-absorption 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 150mg, Pregabalin 75mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called GLA5PR GLARS-NF1 tab.150mg
GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
Pregabalin 75mgDrug
Also called Lyrica Capsule 75mg
Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
| Study group | Role | What they receive |
|---|---|---|
| GLA5PR GLARS-NF1 tab.150mg(fasted) | Experimental | GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day) Receives: Drug: Pregabalin 150mg |
| GLA5PR GLARS-NF1 tab.150mg(after high fat meal) | Experimental | GLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day) Receives: Drug: Pregabalin 150mg |
| Lyrica Capsule 75mg(after high fat meal) | Active comparator | Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day) Receives: Drug: Pregabalin 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Pharmacokinetic of Pregabalin
Measured: 36hrs
Cmax
Pharmacokinetic of Pregabalin
Measured: 36hrs
Secondary outcomes (5)
AUCinf
Pharmacokinetic of Pregabalin
Measured: 36hrs
Tmax
Pharmacokinetic of Pregabalin
Measured: 36hrs
t1/2
Pharmacokinetic of Pregabalin
Measured: 36hrs
CL/F
Pharmacokinetic of Pregabalin
Measured: 36hrs
Vd/F
Pharmacokinetic of Pregabalin
Measured: 36hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326987
- Sponsor's protocol ID
- GLA5PR-103
- Status last verified
- Dec 2014
- First submitted
- 10 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30497798
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02326987
- Acronym / sponsor ID
- GLA5PR-103
- Conditions
- Healthy
- 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 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Dec 2014 (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 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)".
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 mal-absorption 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-NF1 tab.150mg(fasted) | Experimental | Drug: Pregabalin 150mgGLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day) |
| GLA5PR GLARS-NF1 tab.150mg(after high fat meal) | Experimental | Drug: Pregabalin 150mgGLA5PR GLARS-NF1 tab. 150mg/day(Pregabalin 150mg once a day) |
| Lyrica Capsule 75mg(after high fat meal) | Active comparator | Drug: Pregabalin 75mgLyrica Capsule 150mg/day(Pregabalin 75mg twice a day) |
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
- 17.5~30.5kg/m2(BMI) and ≥ 45kg
Key exclusion criteria (1 listed)
- SBP ≥ 140mmHg or DBP ≥ 90mmHg
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 |
|---|---|---|
| Pregabalin 150mgAlso: GLA5PR GLARS-NF1 tab.150mgGLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day) | Drug | GLA5PR GLARS-NF1 tab.150mg(after high fat meal), GLA5PR GLARS-NF1 tab.150mg(fasted) |
| Pregabalin 75mgAlso: Lyrica Capsule 75mgLyrica Capsule 150mg/day(Pregabalin 75mg twice a day) | Drug | Lyrica Capsule 75mg(after high fat meal) |
Primary outcome
AUClast
Time frame: 36hrs
Pharmacokinetic of Pregabalin
Cmax
Time frame: 36hrs
Pharmacokinetic of Pregabalin
5 secondary outcomes
AUCinf
Time frame: 36hrs
Tmax
Time frame: 36hrs
t1/2
Time frame: 36hrs
CL/F
Time frame: 36hrs
Vd/F
Time frame: 36hrs
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 30 Dec 2014.
- Derived from this study: PubMed 30497798Kim 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregabalin 150mg and Pregabalin 75mg in people with Healthy, run by GL Pharm Tech Corporation.
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 1 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
AUClast (time frame: 36hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326987, which also lists 1 linked publication.
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 30 Dec 2014.