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The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is absorbed and eliminated by the body, with and without the use of a condom, compared to a single oral sildenafil dose and to evaluate the safety of sildenafil cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% Sildenafil Cream (SST-6006) | Experimental | 5% Sildenafil Cream |
|
| Oral Sildenafil 50 mg | Active Comparator | Oral Sildenafil 50 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Sildenafil Cream (SST-6006) | Drug | 5 % Sildenafil Cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Tmax, AUC 0-tlast, AUC 0-t, Kel, AUC0-inf, t1/2, CL/F | 32 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of subjects experiencing TEAEs. | 7 to 10 days |
| Clinical Chemistry Tests | Changes from baseline in clinical chemistry values |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SST Clinical Site | Miami | Florida | United States |
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| Oral Sildenafil 50 mg |
| Drug |
Oral Sildenafil 50 mg |
|
| 1 day |
| Vital Signs | Vital sign changes from pre-dose | 1 day |
| 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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