AzTrials
AzTrials

HealthyPhase 1NCT02327000

A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers

A Phase 1 study testing Pregabalin 150mg and Pregabalin 300mg in people with Healthy, run by GL Pharm Tech Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Pregabalin 150mg and Pregabalin 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Oct 2014to Oct 2014
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 19 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 19~45 years old, Healthy Adult Male Subject
  • 17.5~30.5kg/m2(BMI) and ≥ 40kg(Body Weight)

Who cannot join

  • SBP ≥ 140mmHg or DBP ≥ 90mmHg

About this study

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 300mg

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 tablet 150mg

    GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)

  • Pregabalin 300mgDrug

    Also called GLA5PR GLARS-NF1 tablet 300mg

    GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)

Study groups in NCT02327000
Study groupRoleWhat they receive
GLA5PR GLARS-NF1 tablet 150mgExperimentalGLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day, after meal)
Receives: Drug: Pregabalin 150mg
GLA5PR GLARS-NF1 tablet 300mgExperimentalGLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day, after meal)
Receives: Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 450mgExperimentalGLA5PR GLARS-NF1 tablet 450mg/day(Pregabalin 150mg 1 tablet and Pregabalin 300mg 1 tablet, 1 times a day, after meal)
Receives: Drug: Pregabalin 150mg; Drug: Pregabalin 300mg
GLA5PR GLARS-NF1 tablet 600mgExperimentalGLA5PR GLARS-NF1 tablet 600mg/day(Pregabalin 300mg, 2 tablets 1 times a day, after meal)
Receives: Drug: Pregabalin 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUClast

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

  2. Cmax

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

Secondary outcomes (5)

  1. AUCinf

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

  2. Tmax

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

  3. t1/2

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

  4. CL/F

    Pharmacokinetic of Pregabalin

    Measured: 36hrs

  5. 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.

  1. First posted30 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02327000
Sponsor's protocol ID
GLA5PR-104
Status last verified
Dec 2014
First submitted
10 Dec 2014
Last updated
30 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30349198

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pregabalin 150mg and Pregabalin 300mg 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 NCT02327000, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in