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| Name | Class |
|---|---|
| Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V. | OTHER |
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the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Viagra® 100 mg tablet, administered with water |
|
| Treatment B | Active Comparator | Sildenafil 100 mg CT administered with water |
|
| Treatment C | Active Comparator | Sildenafil 100 mg CT administered without water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Viagra® 100 mg tablet, administered with water single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-T and Cmax of sildenafil | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of sildenafil | 28 days | |
| Tmax and half-life of sildenafil | 28 days | |
| Adverse events and vital signs |
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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 | Col. Arenal Tepepan | Mexico City | 14610 | Mexico |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Blood samples for the analysis of sildenafil in plasma |
| Drug |
Blood samples for the analysis of sildenafil in plasma |
|
| Treatment B | Drug | Sildenafil 100 mg CT administered with water single dose |
|
| Blood samples for the analysis of sildenafil in plasma | Other | Blood samples for the analysis of sildenafil in plasma |
|
| Treatment C | Drug | Sildenafil 100 mg CT administered without water single dose |
|
| Blood samples for the analysis of sildenafil in plasma | Other | Blood samples for the analysis of sildenafil in plasma |
|
| 28 days |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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