drugset / Trial / NCT02201342
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
Phase 1/2
Completed
36 enrolled
Mezzion Pharma Co. Ltd
National Heart, Lung, and Blood Institute (NHLBI) · collabPediatric Heart Network · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Udenafil | Small molecule | 37.5 mg | — |
| Subject | Udenafil | Small molecule | 87.5 mg | — |
| Subject | Udenafil | Small molecule | 125 mg | — |