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To evauate pharmacokinetics of GLA5PR tablet according to the renal function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of GLA5PR 75 mg as 60~89 mL/min | Experimental | Administration of GLA5PR 75 mg as 60~89 mL/min(CLcr) |
|
| Administration of GLA5PR 75 mg over 90 mL/min | Experimental | Administration of GLA5PR 75 mg over 90 mL/min(CLcr) |
|
| Administration of GLA5PR 150 mg as 60~89 mL/min | Experimental | Administration of GLA5PR 150 mg as 60~89 mL/min(CLcr) |
|
| Administration of GLA5PR 150 mg over 90 mL/min | Experimental | Administration of GLA5PR 150 mg over 90 mL/min(CLcr) |
|
| Administration of GLA5PR 75 mg as 30~59 mL/min | Experimental | Administration of GLA5PR 75 mg as 30~59 mL/min(CLcr) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLA5PR tablet 75 mg | Drug | GLARS-NF3 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cmax of Pregabalin | Cmax | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| The AUClast of Pregabalin | AUClast | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax of Pregabalin | tmax | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration |
| t1/2beta of Pregabalin | t1/2beta |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Hyuk Jung, MS | Contact | 82-31-739-5220 | 404 | jhjung@glpt.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Minchang Kwon, Ph. D | GL PharmTech Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| GLA5PR tablet 150 mg | Drug | GLARS-NF3 tablet |
|
| Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| AUCinf of Pregabalin | AUCinf | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| CL/F of Pregabalin | CL/F | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| Vz/F of Pregabalin | Vz/F | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |