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This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are:
Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Within 14 hours post dose | |
| Cmax | Within 14 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| T1/2 | Within 14 hours post dose | |
| AUCinf | Within 14 hours post dose | |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1070 | Belgium |
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| 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. |
|
| 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. |
|
| Within 14 hours post dose |
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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