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Completed

NCT Number: 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.

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.

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Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hemorrhage Menopause Metrorrhagia Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage Vaginal Diseases Vaginitis

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Premarin reference tablet (fasted)

Drug

Premarin reference tablet, single dose, fasted conditions

Premarin new tablet (fasted)

Drug

Premarin new tablet, single dose, fasted conditions

Premarin reference tablet (fed)

Drug

Premarin reference tablet, single dose, fed conditions

Premarin new tablet (fed)

Drug

Premarin new tablet, single dose, fed conditions

Primary outcomes

  1. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax

    Time frame: Day 1 to Day 4

  2. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall

    Time frame: Day 1 to Day 4

  3. Plasma unconjugated equilin pharmacokinetic parameter:Cmax

    Time frame: Day 1 to Day 4

  4. Plasma unconjugated equilin pharmacokinetic parameter:AUCall

    Time frame: Day 1 to Day 4

Secondary outcomes

  1. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax

    Time frame: Day 1 to Day 4

  2. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast

    Time frame: Day 1 to Day 4

  3. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf

    Time frame: Day 1 to Day 4

  4. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT

    Time frame: Day 1 to Day 4

  5. Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life

    Time frame: Day 1 to Day 4

  6. Plasma unconjugated equilin pharmacokinetic parameter:Tmax

    Time frame: Day 1 to Day 4

  7. Plasma unconjugated equilin pharmacokinetic parameter:AUClast

    Time frame: Day 1 to Day 4

  8. Plasma unconjugated equilin pharmacokinetic parameter:AUCinf

    Time frame: Day 1 to Day 4

  9. Plasma unconjugated equilin pharmacokinetic parameter:MRT

    Time frame: Day 1 to Day 4

  10. Plasma unconjugated equilin pharmacokinetic parameter:half-life

    Time frame: Day 1 to Day 4

  11. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life

    Time frame: Day 1 to Day 4

  12. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax

    Time frame: Day 1 to Day 4

  13. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax

    Time frame: Day 1 to Day 4

  14. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast

    Time frame: Day 1 to Day 4

  15. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall

    Time frame: Day 1 to Day 4

  16. Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT

    Time frame: Day 1 to Day 4

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2011
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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