Back to resultsPharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Sildenafil Tablet
Sildenafil ODT
Sildenafil ODT
Sponsored by
About this trial
This is an interventional basic science trial for Erectile Dysfunction focused on measuring Bioequivalence Oral Dissolving Tablet
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.
Outcomes
Primary Outcome Measures
AUC(0-t) of sildenafil.
Cmax of sildenafil.
Secondary Outcome Measures
AUC(0-inf) of sildenafil, if data permits.
Half-life of sildenafil, if data permits.
Tmax of sildenafil.
Number of patients with adverse events.
Full Information
NCT ID
NCT01254383
First Posted
November 19, 2010
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01254383
Brief Title
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Bioequivalence Oral Dissolving Tablet
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Tablet
Intervention Description
Tablet, 50 mg, Single Dose
Intervention Type
Drug
Intervention Name(s)
Sildenafil ODT
Intervention Description
Orally Disintegrating Tablet, 50 mg, Single Dose
Intervention Type
Drug
Intervention Name(s)
Sildenafil ODT
Intervention Description
Orally Disintegrating Tablet, 50 mg, Single Dose
Primary Outcome Measure Information:
Title
AUC(0-t) of sildenafil.
Time Frame
Up to 1 month
Title
Cmax of sildenafil.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
AUC(0-inf) of sildenafil, if data permits.
Time Frame
Up to 1 month
Title
Half-life of sildenafil, if data permits.
Time Frame
Up to 1 month
Title
Tmax of sildenafil.
Time Frame
Up to 1 month
Title
Number of patients with adverse events.
Time Frame
Up to 1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
24447534
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481289&StudyName=Pharmacokinetics%20Of%20Sildenafil%20Orally%20Disintegrating%20Tablet%20Formulation%20Versus%20To%20Viagra%AE%20Oral%20Tablet.%20%20
Description
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Learn more about this trial
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
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