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Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy Japanese male subjects between the ages of 20 and 55 years.

- Body Mass Index (BMI) of 17.5 to 30.5 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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- Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood
pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the
development of significant postural symptoms (dizziness, lightheadedness, vertigo)
when going from the supine to standing position.

- Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any
form on either a regular or intermittent basis.

NCT01737203
Pfizer
Completed
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

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