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Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

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NCT01737203

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy Japanese male subjects between the ages of 20 and 55 years.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood
pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the
development of significant postural symptoms (dizziness, lightheadedness, vertigo)
when going from the supine to standing position.

- Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any
form on either a regular or intermittent basis.

NCT01737203
Pfizer
Completed
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

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Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Viagra
    50 mg tablet on Day 1 of each period
    Other Name: sildenafil citrate
  • Drug: sildenafil ODT
    50 mg tablet on Day 1 of each period
  • Active Comparator: Viagra
    Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions
    Intervention: Drug: Viagra
  • Experimental: ODT without water
    Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions
    Intervention: Drug: sildenafil ODT
  • Experimental: ODT with water
    Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions
    Intervention: Drug: sildenafil ODT
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Japanese male subjects between the ages of 20 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
  • Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01737203
A1481315
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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