Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers. Hypothesis: YHD1119 is showing equal equal pharmacokinetics in fasted and fed state.

Detailed Description
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This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers. Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8. Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.

Official Title
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A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers

Conditions
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Peripheral Neuropathic Pain

Intervention / Treatment
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* Drug: YHD1119 300mg
* Drug: YHD1119 300mg


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 30 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 Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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
Interventional Model Description: A randomized, open-label, single dose, cross-over clincial trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>taking YHD1119 (pregabalin 300mg) in fasted state at Period 1 | Drug: YHD1119 300mg<br>* Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition<br>Drug: YHD1119 300mg<br>* Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition<br>|
| Experimental: Group2<br>taking YHD1119 (pregabalin 300mg) in fed state at Period 1 | Drug: YHD1119 300mg<br>* Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition<br>Drug: YHD1119 300mg<br>* Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YHD1119 Cmax | Cmax | 0 - 36hrs | 
| YHD1119 AUC last | AUC last | 0 - 36hrs |