HealthyPhase 1NCT02955472

Bioequivalence Study of Two Formulations of Pregabalin CR (Controlled-release) Table 150 mg

A Phase 1 study testing GLA5PR GLARS-NF3 tablet 150mg and GLA5PR GLARS-NF1 tablet 150mg 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 150mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 150mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 150mg 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 150mg and GLA5PR GLARS-NF1 tablet 150mg
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)

Show all 20Show fewer

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 150 mg and GLA5PR GLARS-NF3 Tablet 150 mg in Healthy Volunteers

Read the detailed description

To assess the single dose pharmacokinetics, safety, and tolerability of GLA5PR GLARS-NF3 tablet 150mg administered regular die relative to GLA5PR GLARS-NF1 tablet 150mg administered regular diet. IP will be administered 1 tablet(150mg) once a day(QD) after evening meal.

Conditions: Healthy
Being tested: GLA5PR GLARS-NF3 tablet 150mg, GLA5PR GLARS-NF1 tablet 150mg
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 150mgDrug
Also called Drug: Test
A new formulation(3rd.) of Pregabalin CR tablet
GLA5PR GLARS-NF1 tablet 150mgDrug
Also called Drug: Comparator
A new formulation(1st.) of Pregabalin CR tablet

Study groups in NCT02955472
Study group	Role	What they receive
Group 1	Other	1. Period 1: GLA5PR GLARS-NF1 tablet 150mg, 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 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). Receives: Drug: GLA5PR GLARS-NF3 tablet 150mg; Drug: GLA5PR GLARS-NF1 tablet 150mg
Group 2	Other	1. Period 1: GLA5PR GLARS-NF3 tablet 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). 2. wash-out period: over 7 days. 3. Period 2: ComparGLA5PR GLARS-NF1 tablet 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). Receives: Drug: GLA5PR GLARS-NF3 tablet 150mg; Drug: GLA5PR GLARS-NF1 tablet 150mg

What is being measured

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

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)
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)

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)
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)
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)
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)
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.

Nov 2016Apr 2017

First posted4 Nov 2016 (estimated)
Study startNov 2016
Primary completionNov 2016
Study completionApr 2017

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02955472
Sponsor's protocol ID: GLAPR-105
Status last verified: Apr 2017
First submitted: 27 Oct 2016
Last updated: 12 Apr 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single Dose, Crossover Phase 1 Study to Compare the Pharmacokinetic Characteristics of GLA5PR GLARS-NF1 Tablet 150 mg and GLA5PR GLARS-NF3 Tablet 150 mg in Healthy Volunteers
ClinicalTrials.gov ID: NCT02955472
Acronym / sponsor ID: GLAPR-105
Conditions: Healthy
Keywords: Neuralgia, Postherpetic, Postherpetic Neuralgia, Diabetic Neuropathies, Diabetic Neuralgia, Diabetic Polyneuropathy, Diabetic Neuropathy, Painful, Neuralgia, Neuropathic Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: Nov 2016 (actual)
Study completion: Apr 2017 (actual)
First posted: 4 Nov 2016 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Other	Drug: GLA5PR GLARS-NF3 tablet 150mg, Drug: GLA5PR GLARS-NF1 tablet 150mg1. Period 1: GLA5PR GLARS-NF1 tablet 150mg, 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 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
Group 2	Other	Drug: GLA5PR GLARS-NF3 tablet 150mg, Drug: GLA5PR GLARS-NF1 tablet 150mg1. Period 1: GLA5PR GLARS-NF3 tablet 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO). 2. wash-out period: over 7 days. 3. Period 2: ComparGLA5PR GLARS-NF1 tablet 150mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).

Who may qualify

Ages: 19 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (20 listed)

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
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)

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
GLA5PR GLARS-NF3 tablet 150mgAlso: Drug: TestA new formulation(3rd.) of Pregabalin CR tablet	Drug	Group 1, Group 2
GLA5PR GLARS-NF1 tablet 150mgAlso: Drug: ComparatorA new formulation(1st.) of Pregabalin CR tablet	Drug	Group 1, Group 2

Primary outcome

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)
Cmax 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)

5 secondary outcomes

AUCinf 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)
Tmax 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)
t1/2 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)
CL/F 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)
Vd/F 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)

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 12 Apr 2017.
Individual participant dataSharing planned: No

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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.

Min-Gul Kim, Ph.D. principal investigator

Chonbuk National University Hospital

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 GLA5PR GLARS-NF3 tablet 150mg and GLA5PR GLARS-NF1 tablet 150mg 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 NCT02955472.

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.