Trials / Completed
CompletedNCT02361619
Dabigatran in an Interaction Probe Drug Cocktail
An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Turku University Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Caffeine | probe |
| DRUG | Diclofenac | probe |
| DRUG | Esomeprazole | probe |
| DRUG | Metoprolol | probe |
| DRUG | Midazolam | probe |
| DRUG | Dabigatran | probe |
| DRUG | Clarithromycin | perpetrator |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-09-01
- Completion
- 2017-06-01
- First posted
- 2015-02-12
- Last updated
- 2018-08-14
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT02361619. Inclusion in this directory is not an endorsement.