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

Back to Search
Print
Bookmark Trial

NCT01389609

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Shinjuku-ku, Tokyo, , Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

HypertensionAmlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients NCT01200407
  1. San Fernando City, La Union
  2. Taclobo, Dumaguete City, Negros Oriental
  3. Albay,
  4. Angono,
  5. Baguio City,
  6. Baguio,
  7. Bulacan,
  8. Calamba,
  9. Cavite,
  10. Cebu City,
  11. Cebu,
  12. Dagupan,
  13. Davao City,
  14. Davao,
  15. Eastwood,
  16. Iloilo City,
  17. Iloilo,
  18. Isabela,
  19. Kalibo Aklan,
  20. Laguna,
  21. Laoag,
  22. Lingayen, Pangasinan,
  23. Makati City,
  24. Makati City,
  25. Makati,
  26. Mandaluyong,
  27. Manila,
  28. Manila,
  29. Manila,
  30. Manila,
  31. Manila,
  32. Manila,
  33. Marikina City,
  34. Marikina,
  35. Metro Manila,
  36. Muntinlupa,
  37. Nueva Vizcaya,
  38. Olongapo,
  39. Pampanga,
  40. Paranaque,
  41. Parañaque,
  42. Pasay,
  43. Pasig City,
  44. Pasig Ciy,
  45. Pasig,
  46. Pasig,
  47. Puerto Princesa,
  48. Quezon City,
  49. Quezon CIty,
  50. Rizal,
  51. San Juan,
  52. Tacloban,
  53. Taguig,
  54. Tarlac,
  55. Tugegarao,
  56. Tuguegarao City,
  57. Tuguegarao City,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypertensionA Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents NCT00389519
  1. Little Rock, Arkansas
  2. Little Rock, Arkansas
  3. Beverly Hills, California
  4. Los Angeles, California
  5. Orange, California
  6. Cocoa Beach, Florida
  7. Lakeland, Florida
  8. Atlanta, Georgia
  9. Augusta, Georgia
  10. Honolulu, Hawaii
  11. Park Ridge, Illinois
  12. Tinley Park, Illinois
  13. Louisville, Kentucky
  14. Shreveport, Louisiana
  15. Bridgeton, Missouri
  16. Las Vegas, Nevada
  17. Las Vegas, Nevada
  18. Toms River, New Jersey
  19. Syracuse, New York
  20. Williamsville, New York
  21. Cary, North Carolina
  22. Chapel Hill, North Carolina
  23. Durham, North Carolina
  24. Sylva, North Carolina
  25. Cincinnati, Ohio
  26. Columbus, Ohio
  27. Norman, Oklahoma
  28. Tulsa, Oklahoma
  29. Portland, Oregon
  30. Portland, Oregon
  31. Philadelphia, Pennsylvania
  32. Kingsport, Tennessee
  33. Memphis, Tennessee
  34. Beaumont, Texas
  35. Houston, Texas
  36. Salt Lake City, Utah
  37. Charlottesville, Virginia
  38. Midlothian, Virginia
  39. Norfolk, Virginia
  40. Buenos Aires,
  41. Buenos Aires,
  42. Buenos Aires,
  43. Buenos Aires,
  44. San Juan,
  45. Tucomán,
  46. Santiago,
  47. Santiago,
  48. Santiago,
  49. Vina del Mar,
  50. Barranquilla,
  51. Bogotá,
  52. Bogotá,
  53. Bogotá,
  54. Medellin,
  55. Medellin,
  56. Medellín,
  57. Ahmedabad,
  58. Ahmedabad,
  59. Bangalore,
  60. Chennai,
  61. Delhi,
  62. Delhi,
  63. Delhi,
  64. Hyderabaad,
  65. Hyderabaad,
  66. Ludhiana,
  67. Mumbai,
  68. Pune,
  69. Trivandrum,
  70. Gdansk,
  71. Katowice,
  72. Lodz,
  73. Lodz,
  74. Poznan,
  75. Szczecin,
  76. Szczecin,
  77. Torun,
  78. Warszawa,
  79. Wroclaw,
  80. Benoni,
  81. Johannesburg,
  82. Port Elizabeth,
  83. Potchefstroom,
  84. Pretoria,
  85. Pretoria,
  86. Pretoria,
  87. Pretoria,
  88. Sandton,
  89. Istanbul,
  90. Istanbul,
  91. Izmir,
  92. Samsun,
  93. Dnepropetrovsk,
  94. Kharkov,
  95. Kiev,
  96. Kyiv,
  97. Lviv,
  98. Odessa,
  99. Simferopol,
  100. Uzhorod,
  101. Vinnitsa,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
HypertensionA Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient NCT00415623
  1. Kasuya-gun, Fujuoka
  2. Chikushino, Fukuoka
  3. Kitakyushu, Fukuoka
  4. Koga, Fukuoka
  5. Sapporo, Hokkaidou
  6. Sapporo, Hokkaido
  7. Yokohama, Kanagawa
  8. Iruma, Saitama
  9. Koshigaya, Saitama
  10. Adachi-ku, Tokyo
  11. Edogawa-ku, Tokyo
  12. Meguro-ku, Tokyo
  13. Setagaya-ku, Tokyo
  14. Sumida, Tokyo
  15. Fukuoka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
HypertensionTreatment of Pediatric Hypertension With Altace Trial NCT00044265
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Augusta, Georgia
  6. Honolulu, Hawaii
  7. Park Ridge, Illinois
  8. Louisville, Kentucky
  9. New Orleans, Louisiana
  10. Baltimore, Maryland
  11. Detroit, Michigan
  12. Kansas City, Missouri
  13. St. Louis, Missouri
  14. Bronx, New York
  15. Great Neck, New York
  16. Cincinnati, Ohio
  17. Cleveland, Ohio
  18. Cleveland, Ohio
  19. Columbus, Ohio
  20. Portland, Oregon
  21. Hershey, Pennsylvania
  22. Philadelphia, Pennsylvania
  23. Philadelphia, Pennsylvania
  24. Pittsburgh, Pennsylvania
  25. Memphis, Tennessee
  26. Nashville, Tennessee
  27. Houston, Texas
  28. Houston, Texas
  29. Charlottesville, Virginia
  30. Madison, Wisconsin
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2011)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01389609
Other Study ID Numbers  ICMJE A0351069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP