Healthy
Conditions
Brief summary
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
Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.
Interventions
DRUGSimvastatin, Dabigatran Etexilate
The subjects receive dabigatran etexilate with and without simvastatin administration
Sponsors
Korea University Guro Hospital
Study design
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 24 hours | maximum plasma concentration |
| AUC | 24 hours, zero to infinite | Area under the plasma concentration versus time curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lag time | 24 hours | thrombin generation assay |
| peak thrombin | 24 hours | thrombin generation assay |
| aPTT | 24 hours | Activated partial thromboplastin time |
| area under the curve | 24 hours | thrombin generation assay |
| velocity index | 24 hours | thrombin generation assay |
| TT | 24 hours | Thrombin time |
Countries
South Korea
Outcome results
None listed