Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
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.
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Aug 2009
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFebruary 1, 2021
January 1, 2021
1 month
July 30, 2009
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC0-T and Cmax of sildenafil
1 month
Secondary Outcomes (5)
AUC0-Tmax and AUCinf of sildenafil
1 month
Tmax and half-life of sildenafil
1 month
adverse events
3 weeks
vital signs
3 weeks
laboratory parameters
3 weeks
Study Arms (4)
Viagra 50 mg tablet, administered with water.
ACTIVE COMPARATORFormulation B ODT tablet 50 mg, administered without water.
EXPERIMENTALFormulation C ODT tablet 50 mg, administered without water.
EXPERIMENTALFormulation D ODT tablet 50 mg, administered without water.
EXPERIMENTALInterventions
Commercial tablet, 50 mg, single dose administered with water
Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
ODT, 50 mg, single dose administered without water
ODT, 50 mg, single dose, administered without water
Eligibility Criteria
You may qualify if:
- Healthy subjects
- Weight: BMI from 17.5 to 30.5
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
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
July 30, 2009
First Posted
July 31, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 1, 2021
Record last verified: 2021-01