NCT03728101CompletedPhase 1
A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
Korea University Guro Hospital1 site in 1 country12 target enrollmentStarted: November 16, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- AUC
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Male
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
Single arm
Experimental
- Dabigatran etexilate
- Simvastatin + Dabigatran etexilate
Intervention: Simvastatin, Dabigatran Etexilate (Drug)
Outcomes
Primary Outcomes
AUC
Time Frame: 24 hours, zero to infinite
Area under the plasma concentration versus time curve
Cmax
Time Frame: 24 hours
maximum plasma concentration
Secondary Outcomes
- peak thrombin(24 hours)
- velocity index(24 hours)
- aPTT(24 hours)
- TT(24 hours)
- lag time(24 hours)
- area under the curve(24 hours)
Investigators
Hyewon Chung
Clinical instructor
Korea University Guro Hospital
Study Sites (1)
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