Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lyrica 150Mg Capsule
* Drug: YNP-1807 330Mg Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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 menopausal(menstruation for 2 years minimum) surgery infertility Exclusion Criteria: Any history of drug overdose or dependence Female who is pregnant or nursing AST, ALT > ULN*1.25 Total bilirubin > ULN*1.5 CPK > ULN*1.5

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YNP-1807 Tablet(Pregabalin 330mg)<br>YNP-1807(Pregabalin 330mg), QD | Drug: YNP-1807 330Mg Tablet<br>* 330 mg oral administered (QD)<br>|
| Active Comparator: Lyrica Capsule(Pregabalin 150mg)<br>Lyrica Capsule(Pregabalin 150mg), BID | Drug: Lyrica 150Mg Capsule<br>* 150 mg oral administered (BID)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 : AUCτ,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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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(AUCτ) of Pregabalin |  | Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours |