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.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause

Intervention / Treatment
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* Drug: Premarin reference tablet (fasted)
* Drug: Premarin new tablet (fasted)
* Drug: Premarin reference tablet (fed)
* Drug: Premarin new tablet (fed)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Premarin reference tablet as a single oral dose under fasted conditions | Drug: Premarin reference tablet (fasted)<br>* Premarin reference tablet, single dose, fasted conditions<br>|
| Experimental: B<br>Premarin new tablet as a single oral dose under fasted conditions | Drug: Premarin new tablet (fasted)<br>* Premarin new tablet, single dose, fasted conditions<br>|
| Experimental: C<br>Premarin reference tablet as a single oral dose under fed conditions | Drug: Premarin reference tablet (fed)<br>* Premarin reference tablet, single dose, fed conditions<br>|
| Experimental: D<br>Premarin new tablet as a single oral dose under fed conditions | Drug: Premarin new tablet (fed)<br>* Premarin new tablet, single dose, fed conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:Cmax |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:AUCall |  | Day 1 to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:Tmax |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:AUClast |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:AUCinf |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:MRT |  | Day 1 to Day 4 | 
| Plasma unconjugated equilin pharmacokinetic parameter:half-life |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall |  | Day 1 to Day 4 | 
| Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT |  | Day 1 to Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated