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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Braganca Paulista, SP, 12916-900 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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;

NCT00904748
Pfizer
Completed
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate In Healthy Male Subjects, Fasting Dosing, Being The Test Formulation Sildenafil Citrate 100 Mg CT , And The Reference Formulation Sildenafil Citrate 100 Mg Film-Coated Tablets (Viagra®), Both Formulations Manufactured By Laboratórios Pfizer Ltda.
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Bio-equivalence between two formulations of sildenafil citrate
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Erectile Dysfunction
  • Drug: sildenafil citrate 100 mg CT
    sildenafil citrate 100 mg CT, single dose without water
  • Drug: sildenafil citrate 100 mg CT
    sildenafil citrate 100 mg CT, single dose with water
  • Drug: Viagra®
    sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
  • Experimental: Test 1
    Intervention: Drug: sildenafil citrate 100 mg CT
  • Experimental: Test 2
    Intervention: Drug: sildenafil citrate 100 mg CT
  • Active Comparator: Reference
    Intervention: Drug: Viagra®
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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;
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00904748
A1481272
JPJ 39/09
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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