Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

Back to Search
Print
Bookmark Trial

NCT01443208

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seoul, , 110-744, Korea, Republic of
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.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects

- Between the ages of 18 and 55 years, inclusive

- 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


- Elevated risk of suicide, in the opinion of the investigator or expert consultant


- Pregnant or nursing females


- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception

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

Major Depressive DisorderA Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression NCT00644982
  1. Cairns, Queensland
  2. Everton Park, Queensland
  3. North Cairns, Queensland
  4. Box Hill, Victoria
  5. Heidelberg, Victoria
  6. West Heidelberg, Victoria
  7. West Perth, Western Australia
  8. Adana,
  9. Ankara,
  10. Diyarbakir,
  11. Istanbul,
  12. Izmir,
  13. Izmit,
  14. Malatya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderStudy Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder NCT00384033
  1. Beverly Hills, California
  2. Burbank, California
  3. Encino, California
  4. Los Alamitos, California
  5. Newport Beach, California
  6. Northridge, California
  7. Orange, California
  8. Pasadena, California
  9. Upland, California
  10. South Miami, Florida
  11. St. Petersburg, Florida
  12. Edwardsville, Illinois
  13. Farmington Hills, Michigan
  14. Flint, Michigan
  15. Okemos, Michigan
  16. Clementon, New Jersey
  17. Dayton, Ohio
  18. Portland, Oregon
  19. Philadelphia, Pennsylvania
  20. Salt Lake City, Utah
  21. Seattle, Washington
  22. Brown Deer, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderRelapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder NCT00887224
  1. Beverly Hills, California
  2. Encino, California
  3. Los Alamitos, California
  4. Orange, California
  5. Upland, California
  6. Aurora, Colorado
  7. Jacksonville, Florida
  8. South Miami, Florida
  9. St. Petersburg, Florida
  10. St. Petersburg, Florida
  11. Atlanta, Georgia
  12. Smyrna, Georgia
  13. Hoffman Estates, Illinois
  14. Rockville, Maryland
  15. New York, New York
  16. New York, New York
  17. Rochester, New York
  18. Dayton, Ohio
  19. Portland, Oregon
  20. San Antonio, Texas
  21. Seattle, Washington
  22. Edmonton, Alberta
  23. Medicine Hat, Alberta
  24. Kelowna, British Columbia
  25. Vancouver, British Columbia
  26. Bathurst, New Brunswick
  27. Burlington, Ontario
  28. Ottawa, Ontario
  29. Toronto, Ontario
  30. Gatineau, Quebec
  31. Pointe-Claire, Quebec
  32. Sherbrooke, Quebec
  33. Santiago,
  34. Santiago,
  35. Santiago,
  36. Medellin, Antioquia
  37. Barranquilla, Atlantico
  38. Bogota, Cundinamarca
  39. Bucamaranga, Santander
  40. Rijeka,
  41. Zagreb,
  42. Tallinn,
  43. Tallinn,
  44. Tartu,
  45. Voru,
  46. Vöru,
  47. Espoo,
  48. Helsinki,
  49. Joensuu,
  50. Kuopio,
  51. Seinajoki,
  52. Tampere,
  53. Turku,
  54. Caen,
  55. Dole,
  56. Douai,
  57. Orvault,
  58. Rennes,
  59. Liepaja,
  60. Sigulda,
  61. Sigulda,
  62. Strenci,
  63. Kaunas,
  64. Kaunas,
  65. Vilius,
  66. Vilnius,
  67. Vilnius,
  68. Vilnius,
  69. Skorzewo, Poznan
  70. Szczecin,
  71. Torun,
  72. Tuszyn,
  73. Wroclaw,
  74. Zuromin,
  75. Craiova, Dolj
  76. Brasov,
  77. Bucharest,
  78. Bucuresti,
  79. Bucuresti,
  80. Cluj Napoca,
  81. Bojnice,
  82. Bratislava,
  83. Liptovsky Mikulas,
  84. Michalovce,
  85. Rimavska Sobota,
  86. Trencin,
  87. Cape Town, Western Cape
  88. Durban,
  89. Paarl,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderStudy Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD) NCT01056289
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
Official Title  ICMJE A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
Brief Summary To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: desvenlafaxine
    one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
  • Drug: desvenlafaxine
    one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
  • Drug: desvenlafaxine
    two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
Study Arms  ICMJE
  • Experimental: 50 mg
    Intervention: Drug: desvenlafaxine
  • Experimental: 100 mg
    Intervention: Drug: desvenlafaxine
  • Experimental: 200 mg
    Intervention: Drug: desvenlafaxine
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: September 27, 2011)		36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects
  • Between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Elevated risk of suicide, in the opinion of the investigator or expert consultant
  • Pregnant or nursing females
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01443208
Other Study ID Numbers  ICMJE B2061137
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 December 2011

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