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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.

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
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

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

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
September 16, 2011
Last Updated
March 14, 2012
Sponsor
Pfizer
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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
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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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