Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
NCT ID: NCT01737203
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2012-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Viagra
Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions
Viagra
50 mg tablet on Day 1 of each period
ODT without water
Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions
sildenafil ODT
50 mg tablet on Day 1 of each period
ODT with water
Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions
sildenafil ODT
50 mg tablet on Day 1 of each period
Interventions
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Viagra
50 mg tablet on Day 1 of each period
sildenafil ODT
50 mg tablet on Day 1 of each period
sildenafil ODT
50 mg tablet on Day 1 of each period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion Criteria
* Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
20 Years
55 Years
MALE
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1481315
Identifier Type: -
Identifier Source: org_study_id
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