Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Udenafil

Criteria

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. 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.

2. History of psychiatric diseases.

3. History of drug abuse (alcohol, tobacco or any other).

4. Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).

5. Laboratory tests with clinically significant alterations.

6. Intestinal disorders that may modify absorption.

7. History of allergy to the drug or related drugs.

8. Blood donation within 45 days prior to study initiation.

9. Participation in a clinical trial within 2 months prior to study initiation.

10. History of orthostatic alterations or presyncope.

11. Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.

12. Inability to communicate or social vulnerability.