PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers

Study Overview
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Brief Summary
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This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

Detailed Description
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Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days). Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

Official Title
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A Open-label, Randomized, Crossover Clinical Trial to Assess the PK of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR and the Food Effect of High Fat Diet After Single Dosing in Healthy Male Volunteers

Conditions
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Peripheral Neuropathy Pain

Intervention / Treatment
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* Drug: YHD1119
* Drug: Lyrica


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs Administration of other investigational products within 3 months prior to the first dosing

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHD1119 (Pregabalin 300mg)<br>YHD1119 (Pregabalin 300mg) | Drug: YHD1119<br>* 2 by 2<br>* Other names: Pregabalin 300mg;|
| Active Comparator: Lyrica (Pregabalin 150mg)<br>Lyrica (Pregabalin 150mg) | Drug: Lyrica<br>* 2 by 2<br>* Other names: Pregabalin 150mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Cmax |  | Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 
| Cohort 1: AUCtau |  | Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 
| Cohort 1: Cmax |  | YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours | 
| Cohort 1: AUCtau |  | YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours | 
| Cohort 2: Cmax |  | YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours | 
| Cohort 2: AUCtau |  | YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours |