Drug Interaction Study of Simvastatin and Dabigatran

• Status: Completed
• Trial end date: 2018-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Korea University Guro Hospital
• Treatments: Dabigatran; Simvastatin

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