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

NCT02952937 | Completed Phase 1

• 1 other identifier: GLAPR-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Neuralgia, Postherpetic; Postherpetic Neuralgia; Diabetic Neuropathies; Diabetic Neuralgia; Diabetic Polyneuropathy; Diabetic Neuropathy, Painful; Neuralgia; Neuropathic Pain; Pregabalin; Pharmacokinetics; Bioequivalent

Outcome Measures

Primary Outcomes (2)

• AUClast of Pregabalin

  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

  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

  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

  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

  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

  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

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

Other Outcomes (1)

• Adverse events, Vital signs, Physical examinations, Clinical safety laboratories and 12-lead EKG.

  Through study completion(Post-study Visit), an average of 1 month

Study Arms (2)

Group 1

OTHER

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).

Drug: GLA5PR GLARS-NF3 tablet 300mg; Drug: GLA5PR GLARS-NF1 tablet 300mg

Group 2

OTHER

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).

Drug: GLA5PR GLARS-NF3 tablet 300mg; Drug: GLA5PR GLARS-NF1 tablet 300mg

Interventions

GLA5PR GLARS-NF3 tablet 300mg DRUG

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

Also known as: Test drug

Group 1; Group 2

GLA5PR GLARS-NF1 tablet 300mg DRUG

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

Also known as: Comparator drug

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GL Pharm Tech Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Diabetic Neuropathies; Neuralgia

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Min-Gul Kim, Ph.D.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)