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.

Pfizer72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Primary Ovarian Insufficiency Vaginitis Metrorrhagia Menopause

Interventions

Premarin reference tablet (fasted)DRUG

Premarin reference tablet, single dose, fasted conditions

Premarin new tablet (fasted)DRUG

Premarin new tablet, single dose, fasted conditions

Premarin reference tablet (fed)DRUG

Premarin reference tablet, single dose, fed conditions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax

Time frame: Day 1 to Day 4

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall

Time frame: Day 1 to Day 4

Plasma unconjugated equilin pharmacokinetic parameter:Cmax

Time frame: Day 1 to Day 4

Plasma unconjugated equilin pharmacokinetic parameter:AUCall

Time frame: Day 1 to Day 4

Secondary Outcomes

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax

Time frame: Day 1 to Day 4

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast

Time frame: Day 1 to Day 4

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf

Time frame: Day 1 to Day 4

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT

Time frame: Day 1 to Day 4

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life

Time frame: Day 1 to Day 4

Plasma unconjugated equilin pharmacokinetic parameter:Tmax

Time frame: Day 1 to Day 4

Plasma unconjugated equilin pharmacokinetic parameter:AUClast

Data from ClinicalTrials.gov

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