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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

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Shinjyuku-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.
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.

NCT01436513
Pfizer
Completed
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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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.
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Primary Ovarian Insufficiency
  • Vaginitis
  • Metrorrhagia
  • Menopause
  • 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
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
March 2012
March 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
45 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01436513
B2811002
3117X3-1112
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

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

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