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A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Hyperplasia, Overactive Urinary Bladder, Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

- Healthy male subjects between the ages of 40 and 55 years, inclusive

- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
(110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant haematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION)
regardless of whether or not this event was temporally associated with the use of a
PDE5 inhibitor.

NCT00814736
Pfizer
Completed
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

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