Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Udenafil · 1 trial · 2 indications
AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
| Arm | Type | Description |
|---|---|---|
| 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. |
| Placebo + Udenafil 150 mg | EXPERIMENTAL | Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. |
| Placebo + Placebo | PLACEBO_COMPARATOR | Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. |
| Name | Type | Description |
|---|---|---|
| Udenafil | DRUG | Udenafil tablets |
| Placebo | DRUG | Placebo tablets |
Inclusion Criteria: 1. Sign a letter of informed consent prior to performing any procedure. 2. Male 3. Clinically healthy 4. Age between 18 and 55 years old. 5. Body Mass Index (BMI) between 18.5 and 24.9. 6. Capability and disposition to attend clinical intervention period Exclusion Criteria: 1....
Udenafil is an investigational small molecule being developed for the treatment of erectile dysfunction. It is currently in Phase 1 clinical development. The drug is being studied in healthy male volunteers to evaluate its safety and pharmacokinetic profile.
Udenafil is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
Udenafil is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, involving 83 participants.
Udenafil has one completed clinical trial registered under NCT01967264, titled 'Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults.' This Phase 1 study enrolled 83 healthy male volunteers in Mexico and was placebo-controlled, randomized, and double-blind.
Udenafil is a phosphodiesterase 5 inhibitor, as indicated by the condition listed in its clinical trial. It is being studied for its effects in treating erectile dysfunction by targeting the phosphodiesterase 5 enzyme pathway.