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The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viagra 50 mg tablet, administered with water. | Active Comparator |
| |
| Formulation B ODT tablet 50 mg, administered without water. | Experimental |
| |
| Formulation C ODT tablet 50 mg, administered without water. | Experimental |
| |
| Formulation D ODT tablet 50 mg, administered without water. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viagra 50 mg tablet | Drug | Commercial tablet, 50 mg, single dose administered with water |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-T and Cmax of sildenafil | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-Tmax and AUCinf of sildenafil | 1 month | |
| Tmax and half-life of sildenafil | 1 month | |
| adverse events |
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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 | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Formulation B ODT tablet 50 mg | Drug | Oral disintegrating tablet (ODT), 50 mg, single dose administered without water |
|
| Formulation C ODT tablet 50 mg | Drug | ODT, 50 mg, single dose administered without water |
|
| Formulation D ODT tablet 50 mg | Drug | ODT, 50 mg, single dose, administered without water |
|
| 3 weeks |
| vital signs | 3 weeks |
| laboratory parameters | 3 weeks |
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D013607 | Tablets |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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