Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

NCT00902512

Last updated date
Study Location
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., 14610, Mexico
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Males
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Healthy MalesStudy Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
NCT00902512
  1. Col. Arenal Tepepan, Mexico D.F.
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
Official Title  ICMJE Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Males
Intervention  ICMJE
  • 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
  • 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
  • Drug: Treatment C
    Sildenafil 100 mg CT administered without water single dose
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Viagra® 100 mg tablet, administered with water
    Interventions:
    • Drug: Treatment A
    • Drug: Blood samples for the analysis of sildenafil in plasma
  • Active Comparator: Treatment B
    Sildenafil 100 mg CT administered with water
    Interventions:
    • Drug: Treatment B
    • Other: Blood samples for the analysis of sildenafil in plasma
  • Active Comparator: Treatment C
    Sildenafil 100 mg CT administered without water
    Interventions:
    • Drug: Treatment C
    • Other: Blood samples for the analysis of sildenafil in plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2009)
36
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00902512
Other Study ID Numbers  ICMJE A1481267
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP