Drug Interaction Study of Simvastatin and Dabigatran

NCT ID: NCT03728101

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2018-12-15

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.

Conditions

Healthy

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single arm

• Dabigatran etexilate
• Simvastatin + Dabigatran etexilate

Group Type: EXPERIMENTAL

Simvastatin, Dabigatran Etexilate

Intervention Type: DRUG

The subjects receive dabigatran etexilate with and without simvastatin administration

Interventions

Simvastatin, Dabigatran Etexilate

The subjects receive dabigatran etexilate with and without simvastatin administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyewon Chung

Clinical instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyewon Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Instructor

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SD-DDI

Identifier Type: -

Identifier Source: org_study_id