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Trial record 1 of 1 for:    NCT00950404
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Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

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ClinicalTrials.gov Identifier: NCT00950404
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE July 30, 2009
First Posted Date  ICMJE July 31, 2009
Last Update Posted Date February 1, 2021
Study Start Date  ICMJE August 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
AUC0-T and Cmax of sildenafil [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
  • AUC0-Tmax and AUCinf of sildenafil [ Time Frame: 1 month ]
  • Tmax and half-life of sildenafil [ Time Frame: 1 month ]
  • adverse events [ Time Frame: 3 weeks ]
  • vital signs [ Time Frame: 3 weeks ]
  • laboratory parameters [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Official Title  ICMJE An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.
Brief Summary The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Viagra 50 mg tablet
    Commercial tablet, 50 mg, single dose administered with water
  • Drug: Formulation B ODT tablet 50 mg
    Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
  • Drug: Formulation C ODT tablet 50 mg
    ODT, 50 mg, single dose administered without water
  • Drug: Formulation D ODT tablet 50 mg
    ODT, 50 mg, single dose, administered without water
Study Arms  ICMJE
  • Active Comparator: Viagra 50 mg tablet, administered with water.
    Intervention: Drug: Viagra 50 mg tablet
  • Experimental: Formulation B ODT tablet 50 mg, administered without water.
    Intervention: Drug: Formulation B ODT tablet 50 mg
  • Experimental: Formulation C ODT tablet 50 mg, administered without water.
    Intervention: Drug: Formulation C ODT tablet 50 mg
  • Experimental: Formulation D ODT tablet 50 mg, administered without water.
    Intervention: Drug: Formulation D ODT tablet 50 mg
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
Estimated Enrollment  ICMJE
 (submitted: July 30, 2009)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects
  • Weight: BMI from 17.5 to 30.5

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00950404
Other Study ID Numbers  ICMJE A1481273
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP