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.

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

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 Overview

• Status: Completed
• Conditions: Menopause; Vaginitis; Metrorrhagia; Primary Ovarian Insufficiency
• Intervention / Treatment: Drug: Premarin reference tablet (fasted); Drug: Premarin new tablet (fasted); Drug: Premarin reference tablet (fed); Drug: Premarin new tablet (fed)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Shinjyuku-ku, Tokyo, Japan
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: bioequivalence; Estrogen Replacement Therapy; menometrorrhagia; climacteric disturbance; Estrogens Conjugated
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hemorrhage; Vaginal Diseases; Uterine Hemorrhage; Vaginitis; Metrorrhagia; Primary Ovarian Insufficiency; Menopause, Premature; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: B2811002; 3117X3-1112