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.
NCT ID: NCT01436513
Last Updated: 2012-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2011-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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A
Premarin reference tablet as a single oral dose under fasted conditions
Premarin reference tablet (fasted)
Premarin reference tablet, single dose, fasted conditions
B
Premarin new tablet as a single oral dose under fasted conditions
Premarin new tablet (fasted)
Premarin new tablet, single dose, fasted conditions
C
Premarin reference tablet as a single oral dose under fed conditions
Premarin reference tablet (fed)
Premarin reference tablet, single dose, fed conditions
D
Premarin new tablet as a single oral dose under fed conditions
Premarin new tablet (fed)
Premarin new tablet, single dose, fed conditions
Interventions
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Premarin reference tablet (fasted)
Premarin reference tablet, single dose, fasted conditions
Premarin new tablet (fasted)
Premarin new tablet, single dose, fasted conditions
Premarin reference tablet (fed)
Premarin reference tablet, single dose, fed conditions
Premarin new tablet (fed)
Premarin new tablet, single dose, fed conditions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
45 Years
75 Years
FEMALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Countries
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Related Links
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Other Identifiers
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3117X3-1112
Identifier Type: -
Identifier Source: secondary_id
B2811002
Identifier Type: -
Identifier Source: org_study_id
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