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

• Gonadal Dysgenesis
• Menopause
• Metrorrhagia
• Primary Ovarian Insufficiency
• Turner Syndrome
• Vaginitis

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

External Links

•   To obtain contact information for a study center near you, click here.