Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01027117 | A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers | PHASE1 | COMPLETED | 18 | — | — | Sep 1, 2009 | Sep 1, 2009 | Jan 29, 2021 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | Revatio 20 mg intact tablet. This is the reference treatment arm. |
| Treatment B | EXPERIMENTAL | Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. |
| Treatment C | EXPERIMENTAL | Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). |
| Name | Type | Description |
|---|---|---|
| Revatio | DRUG | Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject. |
Inclusion Criteria: * Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and cli...