NCT01967264

Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Erectile Dysfunction
• Phosphodiesterase 5 Inhibitor

Interventions

Type	Name	Description
DRUG	Udenafil	Udenafil tablets
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-10-22
• Last updated: 2013-10-22

Locations

1 site across 1 country: Mexico