Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers

Official Title
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A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: RDG-17012 Capsule
* Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 to 45, healthy male subjects(at screening) Subject without a hereditary problems, chronic disease and morbid symptom Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress Exclusion Criteria: Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular) Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test History of drug abuse, or a positive urine drug screen Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study Any condition that, in the view of the investigator, would interfere with study participation

Ages Eligible for Study
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Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDG-17012® capsule<br>RDG-17012 ® capsule(dabigatran etexilate tosylate) | Drug: RDG-17012 Capsule<br>* Dabigatran Etexilate tosylate 150mg<br>|
| Active Comparator: Pradaxa® capsule<br>Pradaxa® capsule(dabigatran etexilate mesylate) | Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule<br>* Dabigatran Etexilate mesylate 150mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC) last of Total dabigatran and Free dabigatran |  | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 | 
| Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran |  | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran |  | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 |