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Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

NCT ID: NCT01967264

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

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.

Conditions

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Erectile Dysfunction Phosphodiesterase 5 Inhibitor

Keywords

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Drug therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Udenafil 150 mg + Udenafil 150 mg

Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil tablets

Udenafil 150 mg + Placebo

Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil tablets

Placebo

Intervention Type DRUG

Placebo tablets

Placebo + Udenafil 150 mg

Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil tablets

Placebo

Intervention Type DRUG

Placebo tablets

Placebo + Placebo

Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

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Udenafil

Udenafil tablets

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Querétaro, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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U1111-1146-1315

Identifier Type: OTHER

Identifier Source: secondary_id

PK-MX031

Identifier Type: -

Identifier Source: org_study_id