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.
Primary Purpose
Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Premarin reference tablet (fasted)
Premarin new tablet (fasted)
Premarin reference tablet (fed)
Premarin new tablet (fed)
Sponsored by
About this trial
This is an interventional basic science trial for Primary Ovarian Insufficiency focused on measuring bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
Arm Description
Premarin reference tablet as a single oral dose under fasted conditions
Premarin new tablet as a single oral dose under fasted conditions
Premarin reference tablet as a single oral dose under fed conditions
Premarin new tablet as a single oral dose under fed conditions
Outcomes
Primary Outcome Measures
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Secondary Outcome Measures
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life
Plasma unconjugated equilin pharmacokinetic parameter:Tmax
Plasma unconjugated equilin pharmacokinetic parameter:AUClast
Plasma unconjugated equilin pharmacokinetic parameter:AUCinf
Plasma unconjugated equilin pharmacokinetic parameter:MRT
Plasma unconjugated equilin pharmacokinetic parameter:half-life
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01436513
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
Keywords
bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Premarin reference tablet as a single oral dose under fasted conditions
Arm Title
B
Arm Type
Experimental
Arm Description
Premarin new tablet as a single oral dose under fasted conditions
Arm Title
C
Arm Type
Experimental
Arm Description
Premarin reference tablet as a single oral dose under fed conditions
Arm Title
D
Arm Type
Experimental
Arm Description
Premarin new tablet as a single oral dose under fed conditions
Intervention Type
Drug
Intervention Name(s)
Premarin reference tablet (fasted)
Intervention Description
Premarin reference tablet, single dose, fasted conditions
Intervention Type
Drug
Intervention Name(s)
Premarin new tablet (fasted)
Intervention Description
Premarin new tablet, single dose, fasted conditions
Intervention Type
Drug
Intervention Name(s)
Premarin reference tablet (fed)
Intervention Description
Premarin reference tablet, single dose, fed conditions
Intervention Type
Drug
Intervention Name(s)
Premarin new tablet (fed)
Intervention Description
Premarin new tablet, single dose, fed conditions
Primary Outcome Measure Information:
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Time Frame
Day 1 to Day 4
Secondary Outcome Measure Information:
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:Tmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:AUClast
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:AUCinf
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:MRT
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated equilin pharmacokinetic parameter:half-life
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall
Time Frame
Day 1 to Day 4
Title
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
Time Frame
Day 1 to Day 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2811002&StudyName=A%20Study%20To%20Compare%20The%20Amount%20Of%20Premarin%20Components%20That%20Is%20Absorbed%20Into%20The%20Blood%20Of%20Japanese%20Healthy%20Postmenopausal%20Women%20Followin
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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.
We'll reach out to this number within 24 hrs