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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2010-023521-38 |
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The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Revatio: 1 x 20 mg IR oral tablet. |
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| Treatment B | Experimental | 2 x 10 mg sildenafil citrate IR oral tablet. |
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| Treatment C | Experimental | 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | Single oral dose of 1 x 20 mg IR oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration. | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | |
| Maximum sildenafil plasma concentration (Cmax) | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose | |
| AUC%extrapolated of sildenafil. | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose |
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Inclusion Criteria:
1) 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 clinical laboratory tests.
2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
3. An informed consent document signed and dated by the subject or a legally acceptable representative.
4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
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 | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Sildenafil citrate | Drug | single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet. |
|
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| sildenafil citrate | Drug | single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose). |
|
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| Tmax - time at which maximum sildenafil plasma concentration occurs | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose |
| Adverse events | From FSFV to LSLV, up to 5 weeks |
| terminal half-life of sildenafil. | Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 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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