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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01436513

Enrollment

Registered

2011-09-19

Start date

2011-10-31

Completion date

2012-03-31

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Metrorrhagia, Primary Ovarian Insufficiency, Vaginitis

Keywords

bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated

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.

Interventions

DRUGPremarin reference tablet (fasted)

Premarin reference tablet, single dose, fasted conditions

DRUGPremarin new tablet (fasted)

Premarin new tablet, single dose, fasted conditions

DRUGPremarin reference tablet (fed)

Premarin reference tablet, single dose, fed conditions

DRUGPremarin new tablet (fed)

Premarin new tablet, single dose, fed conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Measure	Time frame
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 adjusted) pharmacokinetic parameter:Tmax	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
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026