drugset / Trial / NCT02361619
Dabigatran in an Interaction Probe Drug Cocktail
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2015-02
- Primary completion
- 2016-09
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Clarithromycin | Small molecule | — | Oral |
| Subject | Dabigatran | Unknown | — | Oral |
| Subject | Diclofenac | Other / unclassified | — | Oral |
| Subject | Esomeprazole | Small molecule | — | Oral |
| Subject | Metoprolol | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
Indications
No indication recorded.