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The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.
YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.
Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyrica capsule(Pregabalin 150mg) | Active Comparator |
| |
| YHD1119 A(Pregabalin SR 300mg) | Experimental |
| |
| YHD1119 B(Pregabalin SR 300mg) | Experimental |
| |
| YHD1119 C(Pregabalin SR 300mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 300mg a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | 36 hr | |
| AUCtau | 36 hr | |
| Safety monitoring | Laboratory findings Adverse event | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast AUCinfinity Tmax,ss t1/2 | 36 hour | |
| AUCinfinity | 36 hr | |
| Tmax,ss |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul ST.Mary Hospital | Seoul | South Korea |
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| 36 hr |
| t 1/2 | 36 hr |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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