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The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enalapril and avanafil | Experimental |
| |
| amlodipine and avanafil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avanafil and enalapril | Drug | enalapril twice a day for 11 days avanafil/placebo once a day for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the change in standing blood pressure after dosing | -0.5, -0.25, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the pharmacokinetic parameters of taking avanafil with enalapril | AUCc-tau Cmax Cmin Tmax AUC0-t AUC0-inf t1/2 Kel | before dosing and after dosing at the hours of 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36, 48 |
| To measure the change in sitting and lying blood pressure and pulse rate after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyin Yee, PhD | VIVUS LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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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 |
|---|---|
| C553414 | avanafil |
| D004656 | Enalapril |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| avanafil and amlodipine | Drug | amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days |
|
| -0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours |
| To determine the effects of enalapril on blood pressure and pulse rate | -0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours |
| To measure the pharmacokinetic parameters of taking avanafil with amlodipine | AUCc-tau Cmax Cmin Tmax AUC0-t AUC0-inf t1/2 Kel | before dosing and after dosing at the hours of 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36, 48 |
| To determine the effects of amlodipine on blood pressure and pulse rate | -0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D004095 |
| Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |