Drug Interaction Study of Simvastatin and Dabigatran

Healthy Clinical Trial

Official title:

A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728101
• Other study ID #: SD-DDI
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: March 2019
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Simvastatin, Dabigatran Etexilate
The subjects receive dabigatran etexilate with and without simvastatin administration

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	maximum plasma concentration	24 hours
Primary	AUC	Area under the plasma concentration versus time curve	24 hours, zero to infinite
Secondary	aPTT	Activated partial thromboplastin time	24 hours
Secondary	TT	Thrombin time	24 hours
Secondary	lag time	thrombin generation assay	24 hours
Secondary	peak thrombin	thrombin generation assay	24 hours
Secondary	velocity index	thrombin generation assay	24 hours
Secondary	area under the curve	thrombin generation assay	24 hours