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

NCT ID: NCT02952937

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-04-30

Brief 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 regular diet and GLA5PR GLARS-NF1 tablet 300mg administered regular diet.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

1. 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).

Group Type: OTHER

GLA5PR GLARS-NF3 tablet 300mg

Intervention Type: DRUG

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

GLA5PR GLARS-NF1 tablet 300mg

Intervention Type: DRUG

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

Group 2

1. 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).

Group Type: OTHER

GLA5PR GLARS-NF3 tablet 300mg

Intervention Type: DRUG

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

GLA5PR GLARS-NF1 tablet 300mg

Intervention Type: DRUG

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

Interventions

GLA5PR GLARS-NF3 tablet 300mg

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

Intervention Type: DRUG

GLA5PR GLARS-NF1 tablet 300mg

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

Intervention Type: DRUG

Other Intervention Names

Test drug; Comparator drug

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)
• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GL Pharm Tech Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Gul Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

GLAPR-106

Identifier Type: -

Identifier Source: org_study_id