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Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902512
First Posted: May 15, 2009
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Healthy Males Drug: Treatment A Drug: Blood samples for the analysis of sildenafil in plasma Drug: Treatment B Other: Blood samples for the analysis of sildenafil in plasma Drug: Treatment C Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC0-T and Cmax of sildenafil [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • AUC0-inf of sildenafil [ Time Frame: 28 days ]
  • Tmax and half-life of sildenafil [ Time Frame: 28 days ]
  • Adverse events and vital signs [ Time Frame: 28 days ]

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Viagra® 100 mg tablet, administered with water
Drug: Treatment A
Viagra® 100 mg tablet, administered with water single dose
Drug: Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
Active Comparator: Treatment B
Sildenafil 100 mg CT administered with water
Drug: 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
Active Comparator: Treatment C
Sildenafil 100 mg CT administered without water
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902512


Locations
Mexico
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., Mexico, 14610
Sponsors and Collaborators
Pfizer
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00902512     History of Changes
Other Study ID Numbers: A1481267
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: June 1, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents