Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
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
1 other identifier
interventional
36
1 country
1
Brief Summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 1, 2021
January 1, 2021
3 months
November 19, 2010
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUC(0-t) of sildenafil.
Up to 1 month
Cmax of sildenafil.
Up to 1 month
Secondary Outcomes (4)
AUC(0-inf) of sildenafil, if data permits.
Up to 1 month
Half-life of sildenafil, if data permits.
Up to 1 month
Tmax of sildenafil.
Up to 1 month
Number of patients with adverse events.
Up to 1 month
Study Arms (3)
Treatment A
ACTIVE COMPARATORViagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
Treatment B
EXPERIMENTALSildenafil ODT tablet 50 mg, administered without water under fasted conditions
Treatment C
EXPERIMENTALSildenafil ODT tablet 50 mg, administered with water under fasted conditions.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Publications (1)
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.
PMID: 24447534DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2010
First Posted
December 6, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 1, 2021
Record last verified: 2021-01