drugset / Trial / NCT02956109
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers
RandomizedCrossoverOpen-labelOther
Summary
Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.
Timeline
- Start
- 2016-11-16
- Primary completion
- 2016-12-22
- Completion
- 2017-03-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Finerenone | Small molecule | 1.25 mg | — |
| Comparator | Finerenone | Small molecule | 10 mg | — |
Indications
No indication recorded.