Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.

Detailed Description
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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): a) Udenafil-Udenafil b) Udenafil- Placebo c) Placebo-Udenafil d) Placebo-Placebo 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.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.

Conditions
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Erectile Dysfunction, Phosphodiesterase 5 Inhibitor

Intervention / Treatment
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* Drug: Udenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign a letter of informed consent prior to performing any procedure. Male Clinically healthy Age between 18 and 55 years old. Body Mass Index (BMI) between 18.5 and 24.9. Capability and disposition to attend clinical intervention period Exclusion Criteria: Current use of any allopathic, over the counter (OTC) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation. History of psychiatric diseases. History of drug abuse (alcohol, tobacco or any other). Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort). Laboratory tests with clinically significant alterations. Intestinal disorders that may modify absorption. History of allergy to the drug or related drugs. Blood donation within 45 days prior to study initiation. Participation in a clinical trial within 2 months prior to study initiation. History of orthostatic alterations or presyncope. Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals. Inability to communicate or social vulnerability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil 150 mg + Udenafil 150 mg<br>Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. | Drug: Udenafil<br>* Udenafil tablets<br>|
| Experimental: Udenafil 150 mg + Placebo<br>Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. | Drug: Udenafil<br>* Udenafil tablets<br>Drug: Placebo<br>* Placebo tablets<br>|
| Experimental: Placebo + Udenafil 150 mg<br>Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3. | Drug: Udenafil<br>* Udenafil tablets<br>Drug: Placebo<br>* Placebo tablets<br>|
| Placebo Comparator: Placebo + Placebo<br>Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3. | Drug: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy