Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

NCT00902512 | Completed Phase 4

• 1 other identifier: A1481267
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (1)

• AUC0-T and Cmax of sildenafil

  28 days

Secondary Outcomes (3)

• AUC0-inf of sildenafil

  28 days

• Tmax and half-life of sildenafil

  28 days

• Adverse events and vital signs

  28 days

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

Viagra® 100 mg tablet, administered with water

Drug: Treatment A; Drug: Blood samples for the analysis of sildenafil in plasma

Treatment B

ACTIVE COMPARATOR

Sildenafil 100 mg CT administered with water

Drug: Treatment B; Other: Blood samples for the analysis of sildenafil in plasma

Treatment C

ACTIVE COMPARATOR

Sildenafil 100 mg CT administered without water

Drug: Treatment C; Other: Blood samples for the analysis of sildenafil in plasma

Interventions

Treatment A DRUG

Viagra® 100 mg tablet, administered with water single dose

Treatment A

Blood samples for the analysis of sildenafil in plasma DRUG

Blood samples for the analysis of sildenafil in plasma

Treatment A

Treatment B DRUG

Sildenafil 100 mg CT administered with water single dose

Treatment B

Treatment C DRUG

Sildenafil 100 mg CT administered without water single dose

Treatment C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead
• Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.: collaborator

Study Sites (1)

Pfizer Investigational Site

Col. Arenal Tepepan, Mexico City, 14610, Mexico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

ME (1)