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NCT00902512 Clinical Trial

Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Healthy Males Clinical Trial

Official title:
Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00902512
Other study ID # A1481267
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2009
Est. completion date April 2009

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment A
Viagra® 100 mg tablet, administered with water single dose
• Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
• Treatment B
Sildenafil 100 mg CT administered with water single dose
Other:
• Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
Drug:
• Treatment C
Sildenafil 100 mg CT administered without water single dose
Other:
• Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma

Locations
Country Name City State
Mexico Pfizer Investigational Site Col. Arenal Tepepan Mexico D.F.

Sponsors (2)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC0-T and Cmax of sildenafil 28 days
Secondary AUC0-inf of sildenafil 28 days
Secondary Tmax and half-life of sildenafil 28 days
Secondary Adverse events and vital signs 28 days
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