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NCT01436513 Clinical 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.

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01436513
Other study ID # B2811002
Secondary ID 3117X3-1112
Status Completed
Phase Phase 1
First received September 16, 2011
Last updated March 14, 2012
Start date October 2011
Est. completion date March 2012

Study information
Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Japan Pfizer Investigational Site Shinjyuku-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax Day 1 to Day 4 No
Primary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall Day 1 to Day 4 No
Primary Plasma unconjugated equilin pharmacokinetic parameter:Cmax Day 1 to Day 4 No
Primary Plasma unconjugated equilin pharmacokinetic parameter:AUCall Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life Day 1 to Day 4 No
Secondary Plasma unconjugated equilin pharmacokinetic parameter:Tmax Day 1 to Day 4 No
Secondary Plasma unconjugated equilin pharmacokinetic parameter:AUClast Day 1 to Day 4 No
Secondary Plasma unconjugated equilin pharmacokinetic parameter:AUCinf Day 1 to Day 4 No
Secondary Plasma unconjugated equilin pharmacokinetic parameter:MRT Day 1 to Day 4 No
Secondary Plasma unconjugated equilin pharmacokinetic parameter:half-life Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall Day 1 to Day 4 No
Secondary Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT Day 1 to Day 4 No
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