Last reviewed · How we verify
Single-center, Open-label, Randomized, Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag (ACT-293987) Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
Details
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2016-06 |
| Completion | 2016-06 |
Conditions
- Healthy Subjects
Interventions
- Selexipag (adult formulation)
- Selexipag (pediatric formulation)
Primary outcomes
- Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679 — From predose until 72 hours postdose for each treatment period
AUC(0-inf) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to the extrapolated infinite time - Maximum plasma concentration (Cmax) of selexipag and ACT-333679 — From predose until 72 hours postdose for each treatment period
Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679