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Drug Interaction Study of Simvastatin and Dabigatran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03728101
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : March 12, 2019
Information provided by (Responsible Party):
Hyewon Chung, Korea University Guro Hospital

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Simvastatin, Dabigatran Etexilate Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single arm
  • Dabigatran etexilate
  • Simvastatin + Dabigatran etexilate
Drug: Simvastatin, Dabigatran Etexilate
The subjects receive dabigatran etexilate with and without simvastatin administration

Primary Outcome Measures :
  1. Cmax [ Time Frame: 24 hours ]
    maximum plasma concentration

  2. AUC [ Time Frame: 24 hours, zero to infinite ]
    Area under the plasma concentration versus time curve

Secondary Outcome Measures :
  1. aPTT [ Time Frame: 24 hours ]
    Activated partial thromboplastin time

  2. TT [ Time Frame: 24 hours ]
    Thrombin time

  3. lag time [ Time Frame: 24 hours ]
    thrombin generation assay

  4. peak thrombin [ Time Frame: 24 hours ]
    thrombin generation assay

  5. velocity index [ Time Frame: 24 hours ]
    thrombin generation assay

  6. area under the curve [ Time Frame: 24 hours ]
    thrombin generation assay

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03728101

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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Sponsors and Collaborators
Korea University Guro Hospital
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Principal Investigator: Hyewon Chung, MD, PhD Clinical Instructor
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Responsible Party: Hyewon Chung, Clinical instructor, Korea University Guro Hospital Identifier: NCT03728101    
Other Study ID Numbers: SD-DDI
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors