Drug Interaction Study of Simvastatin and Dabigatran

Korea University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Simvastatin, Dabigatran Etexilate

Study type: Interventional

Funder types: Other

Identifiers

NCT03728101

SD-DDI

Details and patient eligibility

About

The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults

Full description

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

Enrollment: 12 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

12 participants in 1 patient group

Single arm

Experimental group

Description:

* Dabigatran etexilate * Simvastatin + Dabigatran etexilate

Treatment:

Drug: Simvastatin, Dabigatran Etexilate