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HealthyPhase 1NCT02952937

Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg

A Phase 1 study testing GLA5PR GLARS-NF3 tablet 300mg and GLA5PR GLARS-NF1 tablet 300mg in people with Healthy, run by GL Pharm Tech Corporation at 1 site in South Korea.

Completed

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

Official record
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Trial summary

The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 300mg administered… Read more about this study

Who is it for?
Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GLA5PR GLARS-NF3 tablet 300mg and GLA5PR GLARS-NF1 tablet 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
Nov 2016to Apr 2017
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male subjects who, at the time of screening, are the age of older than 19 years.
  • Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg.
  • There is no congenital disease or within 3 years of chronic diseases.
  • Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests.
  • Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products.
  • A subject who has the following clinical laboratory test results
  • ☞ Liver Function Test (AST, ALT) > three times the upper limit of the normal range
  • History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening.
  • A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
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  • A subject who has the following vital signs results in sitting position at the time of the screening :
  • SBP ≤ 90 mmHg or DBP ≤ 60 mmHg.
  • A subject with a history of drug abuse or a positive urine drug screening for drug abuse
  • A subject who has taken the drugs that induce and suppress drug-metabolizing enzymes within 30 days prior to investigational product administration.
  • A smoker who consumes more than 20 cigarettes/days
  • A subject who has taken any ethical-the-counter drug or has taken any over-the-counter drug within 10days before the investigational product administration
  • A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
  • A subject who is unable to take regular diet during the study period.
  • Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs
  • History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.
  • Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • A subject who is not eligible for the study due to reasons on the investigators' judgment.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, Crossover Phase 1 Study to Compare the Pharmacokinetic Characteristics of GLA5PR GLARS-NF1 Tablet 300 mg and GLA5PR GLARS-NF3 Tablet 300 mg in Healthy Volunteers

The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg administered regular diet.

Read the detailed description

To assess the single dose pharmacokinetics, safety, and tolerability of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet. IP will be administered 1 tablet(300mg) once a day(QD) after evening meal.

Conditions
Healthy
Being tested
GLA5PR GLARS-NF3 tablet 300mg, GLA5PR GLARS-NF1 tablet 300mg
Keywords
Neuralgia, Postherpetic, Postherpetic Neuralgia, Diabetic Neuropathies, Diabetic Neuralgia, Diabetic Polyneuropathy, Diabetic Neuropathy, Painful, Neuralgia, Neuropathic Pain, Pregabalin, Pharmacokinetics, Bioequivalent
Medical subject headings
Neuralgia, Postherpetic, Diabetic Neuropathies, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLA5PR GLARS-NF3 tablet 300mgDrug

    Also called Test drug

    A new formulation(3rd.) of Pregabalin CR tablet

  • GLA5PR GLARS-NF1 tablet 300mgDrug

    Also called Comparator drug

    A new formulation(1st.) of Pregabalin CR tablet

Study groups in NCT02952937
Study groupRoleWhat they receive
Group 1Other1. Period 1: GLA5PR GLARS-NF1 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). 2. wash-out period: over 7 days. 3. Period 2: GLA5PR GLARS-NF3 tablet 300mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
Receives: Drug: GLA5PR GLARS-NF3 tablet 300mg; Drug: GLA5PR GLARS-NF1 tablet 300mg
Group 2Other1. Period 1: GLA5PR GLARS-NF3 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). 2. wash-out period: over 7 days. 3. Period 2: GLA5PR GLARS-NF1 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
Receives: Drug: GLA5PR GLARS-NF3 tablet 300mg; Drug: GLA5PR GLARS-NF1 tablet 300mg

What is being measured

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

  1. AUClast of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

  2. Cmax of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

Secondary outcomes (5)

  1. AUCinf of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

  2. Tmax of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

  3. t1/2 of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

  4. CL/F of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

  5. Vd/F of Pregabalin

    Measured: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2016
  4. Study completionApr 2017

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952937
Sponsor's protocol ID
GLAPR-106
Status last verified
Apr 2017
First submitted
31 Oct 2016
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLA5PR GLARS-NF3 tablet 300mg and GLA5PR GLARS-NF1 tablet 300mg 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 6 inclusion and 20 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 12 Apr 2017. 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?

AUClast of Pregabalin (time frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points)). 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 NCT02952937.

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 12 Apr 2017.

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Clinical Trial NCT02952937 | AzTrials