Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Phase 4

Completed

• Conditions: Healthy Males
• Interventions: Drug: Treatment A; Drug: Treatment C; Drug: Treatment B; Other: Blood samples for the analysis of sildenafil in plasma

• Registration Number: NCT00902512
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Treatment A	Viagra® 100 mg tablet, administered with water
Treatment A	Blood samples for the analysis of sildenafil in plasma	Viagra® 100 mg tablet, administered with water
Treatment C	Treatment C	Sildenafil 100 mg CT administered without water
Treatment C	Blood samples for the analysis of sildenafil in plasma	Sildenafil 100 mg CT administered without water
Treatment B	Treatment B	Sildenafil 100 mg CT administered with water
Treatment B	Blood samples for the analysis of sildenafil in plasma	Sildenafil 100 mg CT administered with water

Primary Outcome Measures

Name	Time	Method
AUC0-T and Cmax of sildenafil	28 days

Secondary Outcome Measures

Name	Time	Method
AUC0-inf of sildenafil	28 days
Tmax and half-life of sildenafil	28 days
Adverse events and vital signs	28 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇽 Col. Arenal Tepepan, Mexico D.F., Mexico