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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 regular diet and GLA5PR GLARS-NF1 tablet 150mg administered regular diet.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other |
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| Group 2 | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLA5PR GLARS-NF3 tablet 150mg | Drug | A new formulation(3rd.) of Pregabalin CR tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Vital signs, Physical examinations, Clinical safety laboratories and 12-lead EKG. | Through study completion, upto 3 ~7 days after last PK sample collection |
Inclusion Criteria:
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
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, Ph.D. | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| GLA5PR GLARS-NF1 tablet 150mg | Drug | A new formulation(1st.) of Pregabalin CR tablet |
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| 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) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |