Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

This study has been completed.
Sponsor:
Collaborator:
Investigación Farmacológica y Biofarmacéutica (IFaB)
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00902512
First received: May 13, 2009
Last updated: May 30, 2011
Last verified: May 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-inf of sildenafil [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Tmax and half-life of sildenafil [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Adverse events and vital signs [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902512

Locations
Mexico
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., Mexico, 14610
Sponsors and Collaborators
Pfizer
Investigación Farmacológica y Biofarmacéutica (IFaB)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00902512     History of Changes
Other Study ID Numbers: A1481267
Study First Received: May 13, 2009
Last Updated: May 30, 2011
Health Authority: Mexico: Mexican Health Secretary

Additional relevant MeSH terms:
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014