Trials / Completed
CompletedNCT03728101
Drug Interaction Study of Simvastatin and Dabigatran
A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Korea University Guro Hospital · Academic / Other
- Sex
- Male
- Age
- 19 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simvastatin, Dabigatran Etexilate | The subjects receive dabigatran etexilate with and without simvastatin administration |
Timeline
- Start date
- 2018-11-16
- Primary completion
- 2018-12-15
- Completion
- 2018-12-15
- First posted
- 2018-11-01
- Last updated
- 2019-03-12
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03728101. Inclusion in this directory is not an endorsement.