A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.

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NCT01436513

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Study Location
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese healthy postmenopausal women

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


- History or current evidence of thrombophlebitis, thromboembolic disorders, or any
coagulopathies.


- History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a
documented history of any malignancy, except for basal or squamous cell carcinoma of
skin, which has been treated and fully resolved for a minimal 5 years.


- History or presence of benign or malignant liver tumor that developed during the use
of oral contraceptives or other estrogen-containing products.

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Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, MenopauseA Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
NCT01436513
  1. Shinjyuku-ku, Tokyo
Female
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women
Brief Summary The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
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: Basic Science
Condition  ICMJE
  • Primary Ovarian Insufficiency
  • Vaginitis
  • Metrorrhagia
  • Menopause
Intervention  ICMJE
  • Drug: Premarin reference tablet (fasted)
    Premarin reference tablet, single dose, fasted conditions
  • Drug: Premarin new tablet (fasted)
    Premarin new tablet, single dose, fasted conditions
  • Drug: Premarin reference tablet (fed)
    Premarin reference tablet, single dose, fed conditions
  • Drug: Premarin new tablet (fed)
    Premarin new tablet, single dose, fed conditions
Study Arms  ICMJE
  • Experimental: A
    Premarin reference tablet as a single oral dose under fasted conditions
    Intervention: Drug: Premarin reference tablet (fasted)
  • Experimental: B
    Premarin new tablet as a single oral dose under fasted conditions
    Intervention: Drug: Premarin new tablet (fasted)
  • Experimental: C
    Premarin reference tablet as a single oral dose under fed conditions
    Intervention: Drug: Premarin reference tablet (fed)
  • Experimental: D
    Premarin new tablet as a single oral dose under fed conditions
    Intervention: Drug: Premarin new tablet (fed)
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 16, 2011)		72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese healthy postmenopausal women

Exclusion Criteria:

  • History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
  • History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
  • History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 75 Years   (Adult, Older 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 NCT01436513
Other Study ID Numbers  ICMJE B2811002
3117X3-1112
Has Data Monitoring Committee Not Provided
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 March 2012

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