drugset / Trial / NCT03307252
This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men
RandomizedCrossoverOpen-labelOther
Summary
The primary objective of this trial is to investigate the relative bioavailabilities of digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the following drug transporter inhibitors: Part 1: verapamil (P-gp) and rifampin (OATP1B1/1B3) Part 2: cimetidine (OCT2/MATE) Part 3: probenecid (OAT1/3) The secondary objective is to investigate other potential changes in pharmacokinetics (e.g. in clearance, volume of distribution, etc.) of digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the inhibitors describe above.
Timeline
- Start
- 2017-10-25
- Primary completion
- 2018-05-02
- Completion
- 2018-05-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cimetidine | Small molecule | — | — |
| Subject | Digoxin | Other / unclassified | — | — |
| Subject | Furosemide | Other / unclassified | — | Oral |
| Subject | Metformin | Small molecule | — | Oral |
| Subject | Probenecid | Small molecule | — | — |
| Subject | Rifampicin | Small molecule | — | — |
| Subject | Rosuvastatin | Small molecule | — | — |
| Subject | Verapamil | Other / unclassified | — | — |
Indications
No indication recorded.