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Trial record 1 of 1 for:    NCT00904748
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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate (A1481272)

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ClinicalTrials.gov Identifier: NCT00904748
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : April 4, 2011
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 20, 2009
Results First Submitted Date  ICMJE March 7, 2011
Results First Posted Date  ICMJE April 4, 2011
Last Update Posted Date May 20, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
  • Area Under the Curve (AUC 0-t) [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose ]
    Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).
  • Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose ]
    Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • AUC0-T of Sildenafil (test versus reference formulation) [ Time Frame: one week ]
  • Cmax of Sildenafil (test versus reference formulation) [ Time Frame: one week ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
  • Area Under the Curve From 0 to Infinity (AUC 0-inf ) [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose ]
    Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).
  • Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose ]
    Time at which maximum plasma concentration (Cmax) occurred.
  • Half-life (T 1/2) [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose ]
    Terminal elimination half-life.
  • Number of Participants With Clinically Significant Findings in Vital Signs [ Time Frame: Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose. ]
    Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • AUC0-inf of sildenafil (test versus reference formulation) [ Time Frame: one week ]
  • Tmax of sildenafil (test versus reference formulation) [ Time Frame: one week ]
  • Half-life of sildenafil (test versus reference formulation) [ Time Frame: one week ]
  • Adverse events and vital signs [ Time Frame: one month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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®
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 4, 2010)
47
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
30
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00904748
Other Study ID Numbers  ICMJE A1481272
JPJ 39/09
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 Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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