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Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico D.F., 14610 Mexico
Contact
1-800-718-1021
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

NCT00902512
Pfizer
Completed
Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

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Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Males
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00902512
A1481267
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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