Status:
COMPLETED
Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborating Sponsors:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Conditions:
Healthy Males
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief Summary
the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water...
Eligibility Criteria
Inclusion
- Only healthy male volunteers in the 18-40 age range will be included.
- At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
- The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
- History of hypersensitivity to sildenafil citrate or any components of its formulations
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00902512
Start Date
April 1 2009
End Date
April 1 2009
Last Update
February 1 2021
Active Locations (1)
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1
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico City, Mexico, 14610