Drug Interaction Study of Simvastatin and Dabigatran

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Simvastatin, Dabigatran Etexilate

• Registration Number: NCT03728101
• Lead Sponsor: 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Study Start: 2018-11-16
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-09
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single arm	Simvastatin, Dabigatran Etexilate	* Dabigatran etexilate * Simvastatin + Dabigatran etexilate

Primary Outcome Measures

Name	Time	Method
Cmax	24 hours	maximum plasma concentration
AUC	24 hours, zero to infinite	Area under the plasma concentration versus time curve

Secondary Outcome Measures

Name	Time	Method
peak thrombin	24 hours	thrombin generation assay
velocity index	24 hours	thrombin generation assay
aPTT	24 hours	Activated partial thromboplastin time
TT	24 hours	Thrombin time
lag time	24 hours	thrombin generation assay
area under the curve	24 hours	thrombin generation assay

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of