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
Completed
- Conditions
- MenopauseMetrorrhagiaPrimary Ovarian InsufficiencyVaginitis
- Interventions
- Registration Number
- NCT01436513
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Premarin reference tablet (fasted) Premarin reference tablet as a single oral dose under fasted conditions B Premarin new tablet (fasted) Premarin new tablet as a single oral dose under fasted conditions C Premarin reference tablet (fed) Premarin reference tablet as a single oral dose under fed conditions D Premarin new tablet (fed) Premarin new tablet as a single oral dose under fed conditions
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 adjusted) pharmacokinetic parameter:MRT Day 1 to Day 4 Plasma unconjugated equilin pharmacokinetic parameter:AUCinf 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:half-life Day 1 to Day 4 Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax Day 1 to Day 4 Plasma unconjugated estrone (baseline adjusted) 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 adjusted) pharmacokinetic parameter:AUCinf 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: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:AUCall Day 1 to Day 4 Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT Day 1 to Day 4
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Shinjyuku-ku, Tokyo, Japan