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
Overview
- Phase
- Phase 1
- Intervention
- Premarin reference tablet (fasted)
- Conditions
- Primary Ovarian Insufficiency
- Sponsor
- Pfizer
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
A
Premarin reference tablet as a single oral dose under fasted conditions
Intervention: Premarin reference tablet (fasted)
B
Premarin new tablet as a single oral dose under fasted conditions
Intervention: Premarin new tablet (fasted)
C
Premarin reference tablet as a single oral dose under fed conditions
Intervention: Premarin reference tablet (fed)
D
Premarin new tablet as a single oral dose under fed conditions
Intervention: Premarin new tablet (fed)
Outcomes
Primary Outcomes
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Time Frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Time Frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Time Frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Time Frame: Day 1 to Day 4
Secondary Outcomes
- 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)