Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Erectile Dysfunction Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Erectile Dysfunction
• Phosphodiesterase 5 Inhibitor

• NCT number: NCT01967264
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: August 2013