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The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viagra | Active Comparator | Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions |
|
| ODT without water | Experimental | Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions |
|
| ODT with water | Experimental | Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viagra | Drug | 50 mg tablet on Day 1 of each period |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
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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 | Minato-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| sildenafil ODT | Drug | 50 mg tablet on Day 1 of each period |
|
| sildenafil ODT | Drug | 50 mg tablet on Day 1 of each period |
|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
| Plasma Decay Half-Life (t1/2) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 9 days |
| Diastolic and Systolic Blood Pressure | 9 days |
| 12-lead electrocardiogram (ECG) | 9 days |
| Pulse rate (PR) | 9 days |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | 9 days |
| Mean Residence Time(MRT) | 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |