Status:
COMPLETED
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Detailed Description
Bio-equivalence between two formulations of sildenafil citrate
Eligibility Criteria
Inclusion
- Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.
- Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure measurements, physical and psychological examination, ECG and complementary laboratory examination.
- Able to understand the study nature and objective, including the risks and adverse effects and willing to cooperate with the investigator and act according to all the trial requirements, which is confirmed by signing the Informed Consent Form.
Exclusion
- Hypersensitivity to the study drug or to the chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
- History or presence of hepatic or gastrointestinal diseases, or other condition that affects the drug absorption, distribution, excretion or metabolism
- History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or psychiatric disease; hypo or hypertension of whatever etiology which demands treatment with drugs; history or occurrence of myocardial infarction, angina and/or cardiac failure;
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00904748
Start Date
January 1 2010
End Date
March 1 2010
Last Update
February 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Bragança Paulista, São Paulo, Brazil, 12916-900