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This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions |
|
| Treatment B | Experimental | Sildenafil ODT tablet 50 mg, administered without water under fasted conditions |
|
| Treatment C | Experimental | Sildenafil ODT tablet 50 mg, administered with water under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil Tablet | Drug | Tablet, 50 mg, Single Dose |
| |
| Sildenafil ODT |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) of sildenafil. | Up to 1 month | |
| Cmax of sildenafil. | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf) of sildenafil, if data permits. | Up to 1 month | |
| Half-life of sildenafil, if data permits. | Up to 1 month | |
| Tmax of sildenafil. |
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Inclusion Criteria:
Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
Signed and dated informed consent document.
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 | Singapore | 188770 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24447534 | Derived | Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
Orally Disintegrating Tablet, 50 mg, Single Dose |
|
| Sildenafil ODT | Drug | Orally Disintegrating Tablet, 50 mg, Single Dose |
|
| Up to 1 month |
| Number of patients with adverse events. | Up to 1 month |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |