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Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
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

- Japanese healthy male subjects

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 SBP, a ?10 mm Hg
reduction in DBP and/or the development of significant postural symptoms (dizziness,
lightheadedness, vertigo) when going from the supine to standing position.

NCT01389609
Pfizer
Completed
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

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Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
  • Drug: Doxazosin 4 mg Japanese marketed IR tablet
    Immediate release tablet, 4 mg, single dose
  • Drug: Doxazosin 4 mg ODT with water
    Orally-disintegrating Tablet , 4 mg, single dose with water
  • Drug: Doxazosin 4 mg ODT without water
    Orally-disintegrating Tablet , 4 mg, single dose without water
  • Experimental: A
    Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions
    Intervention: Drug: Doxazosin 4 mg Japanese marketed IR tablet
  • Experimental: B
    Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions
    Intervention: Drug: Doxazosin 4 mg ODT with water
  • Experimental: C
    Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions
    Intervention: Drug: Doxazosin 4 mg ODT without water
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese healthy male subjects

Exclusion Criteria:

  • Baseline orthostatic hypotension defined as a ?20 mm Hg reduction in SBP, a ?10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01389609
A0351069
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

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.

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