Clinical trial NCT01436513: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Ovarian Insufficiency
Vaginitis
Metrorrhagia
Menopause
Keywords: bioequivalence
menometrorrhagia
climacteric disturbance
Estrogen Replacement Therapy
Estrogens Conjugated
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 72
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:Cmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:AUCall
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:Tmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:AUClast
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:AUCinf
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:MRT
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated equilin pharmacokinetic parameter:half-life
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall
timeFrame: Day 1 to Day 4
measure: Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: