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