drugset / Trial / NCT01489488
Relative Bioavailability and Food Effect Study
RandomizedCrossoverOpen-label
Summary
Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults. Secondary objective: To evaluate safety and tolerability measured by physical examination findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events (AEs).
Timeline
- Start
- 2012-01
- Primary completion
- 2012-04
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Riociguat | Other / unclassified | 0.15 mg | Oral |
| Subject | Riociguat | Other / unclassified | 0.3 mg | Oral |
| Subject | Riociguat | Other / unclassified | 1 mg | Oral |
| Subject | Riociguat | Other / unclassified | 2.4 mg | Oral |
Indications
No indication recorded.