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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1146-1315 | Other Identifier | World Health Organization |
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The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.
The drug being tested in this study is called Udenafil. Udenafil is being tested to determine a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and side effects in people who take Udenafil.
The study will enroll approximately 84 patients. Participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.
This single-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil 150 mg + Udenafil 150 mg | Experimental | Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
|
| Udenafil 150 mg + Placebo | Experimental | Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
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| Placebo + Udenafil 150 mg | Experimental | Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
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| Placebo + Placebo | Placebo Comparator | Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Udenafil tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants with Adverse Events | AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG). | 3 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification | AUC(0-last) is a measure of total plasma exposure to the drug from Time 0 to the last measured concentration above the lower limit of quantification (LLOQ). | Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Querétaro | Mexico |
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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 |
|---|---|
| C419664 | udenafil |
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| Placebo | Drug | Placebo tablets |
|
| AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity | Area under the plasma concentration-time curve from time zero extrapolated to infinity. | Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose |
| Cmax: Maximum Observed Plasma Concentration | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration | Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose |
| Terminal Phase Elimination Half-life (T1/2) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |