Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
NCT00902512
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 30 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |