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The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YNP-1807 Tablet(Pregabalin 330mg) | Experimental | YNP-1807(Pregabalin 330mg), QD |
|
| Lyrica Capsule(Pregabalin 150mg) | Active Comparator | Lyrica Capsule(Pregabalin 150mg), BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyrica 150Mg Capsule | Drug | 150 mg oral administered (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part I : AUClast of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours | |
| Part I : Cmax of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours | |
| Part II : AUCĪ,ss of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours | |
| Part II : Cmax,ss of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Part I : AUCinf of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours | |
| Part I : Tmax of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours | |
| Part I : t1/2 of Pregabalin |
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Inclusion Criteria:
19 years to 55 years healthy volunteers adult at screening visit
For male, weight is more than 55 kg, for female, weight is more than 50 kg.
Body mass index(BMI) value : 18.5 to 25.0 kg/m2
If female, should be included one at least as following
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinSoo Park, MD,PhD | Severance Hospital, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Yonsei-ro Seodaemun-gu | 120-752 | South Korea |
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| YNP-1807 330Mg Tablet |
| Drug |
330 mg oral administered (QD) |
|
| 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part I : Vd/F of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part I : CL/F of Pregabalin | 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : Cmin,ss of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : AUClast,ss of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : Tmax,ss of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : t1/2 of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : CLss/F of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : Vdss/F of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : accumulation ratio(Cmax) of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| Part II : accumulation ratio(AUCĪ) of Pregabalin | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D013607 | Tablets |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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