Drug Interaction Study of Simvastatin and Dabigatran

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults

Detailed Description
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Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.

Official Title
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A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: Simvastatin, Dabigatran Etexilate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 19 and 50 years Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg Subjects who agree with performing contraception during the study Subjects who agreed with written informed consent Exclusion Criteria Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug Creatinine clearance is below 60 ml/min Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range Subjects who have clinically significant bleeding Subjects at risk of bleeding Subjects who took drugs which significantly interact with simvastatin or dabigatran prior to dosing Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing Participated in a previous clinical trial within 90 days prior to dosing Subjects with a history of alcohol abuse Subjects who are determined by investigator's decision as unsuitable for clinical trial participation

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: Basic Science
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Dabigatran etexilate Simvastatin + Dabigatran etexilate | Drug: Simvastatin, Dabigatran Etexilate<br>* The subjects receive dabigatran etexilate with and without simvastatin administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum plasma concentration | 24 hours | 
| AUC | Area under the plasma concentration versus time curve | 24 hours, zero to infinite | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aPTT | Activated partial thromboplastin time | 24 hours | 
| TT | Thrombin time | 24 hours | 
| lag time | thrombin generation assay | 24 hours | 
| peak thrombin | thrombin generation assay | 24 hours | 
| velocity index | thrombin generation assay | 24 hours | 
| area under the curve | thrombin generation assay | 24 hours |