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This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Oral Tablet With Water | Active Comparator |
| |
| Experimental Tablet With Water | Experimental |
| |
| Experimental Tablet Without Water | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Single Dose of 50 mg Sildenafil Oral Tablet With Water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of sildenafil | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of a metabolite of sildenafil | 1 day | |
| Safety | 1 day |
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Inclusion Criteria:
Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
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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 | New Haven | Connecticut | 06511 | United States |
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| Sildenafil | Drug | Single Dose of 50 mg Sildenafil Experimental Tablet With Water |
|
| Sildenafil | Drug | Single Dose of 50 mg Sildenafil Experimental Tablet Without Water |
|
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| 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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