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Trial record 1 of 1 for:    NCT01254383
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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

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ClinicalTrials.gov Identifier: NCT01254383
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE December 6, 2010
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE December 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • AUC(0-t) of sildenafil. [ Time Frame: Up to 1 month ]
  • Cmax of sildenafil. [ Time Frame: Up to 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01254383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • AUC(0-inf) of sildenafil, if data permits. [ Time Frame: Up to 1 month ]
  • Half-life of sildenafil, if data permits. [ Time Frame: Up to 1 month ]
  • Tmax of sildenafil. [ Time Frame: Up to 1 month ]
  • Number of patients with adverse events. [ Time Frame: Up to 1 month ]
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 Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Official Title  ICMJE An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water
Brief Summary This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
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 Erectile Dysfunction
Intervention  ICMJE
  • Drug: Sildenafil Tablet
    Tablet, 50 mg, Single Dose
  • Drug: Sildenafil ODT
    Orally Disintegrating Tablet, 50 mg, Single Dose
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
    Intervention: Drug: Sildenafil Tablet
  • Experimental: Treatment B
    Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
    Intervention: Drug: Sildenafil ODT
  • Experimental: Treatment C
    Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.
    Intervention: Drug: Sildenafil ODT
Publications * Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.

*   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: December 3, 2010)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.

Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

Signed and dated informed consent document.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Have baseline orthostatic hypotension
  • Positive drug screen, excessive alcohol and tobacco use
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254383
Other Study ID Numbers  ICMJE A1481289
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 June 2011

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