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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.

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ClinicalTrials.gov Identifier: NCT01436513
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Vaginitis Metrorrhagia Menopause Drug: Premarin reference tablet (fasted) Drug: Premarin new tablet (fasted) Drug: Premarin reference tablet (fed) Drug: Premarin new tablet (fed) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012


Arm Intervention/treatment
Experimental: A
Premarin reference tablet as a single oral dose under fasted conditions
Drug: Premarin reference tablet (fasted)
Premarin reference tablet, single dose, fasted conditions
Experimental: B
Premarin new tablet as a single oral dose under fasted conditions
Drug: Premarin new tablet (fasted)
Premarin new tablet, single dose, fasted conditions
Experimental: C
Premarin reference tablet as a single oral dose under fed conditions
Drug: Premarin reference tablet (fed)
Premarin reference tablet, single dose, fed conditions
Experimental: D
Premarin new tablet as a single oral dose under fed conditions
Drug: Premarin new tablet (fed)
Premarin new tablet, single dose, fed conditions



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436513


Locations
Japan
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01436513     History of Changes
Other Study ID Numbers: B2811002
3117X3-1112
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by Pfizer:
bioequivalence
menometrorrhagia
climacteric disturbance
Estrogen Replacement Therapy
Estrogens Conjugated

Additional relevant MeSH terms:
Vaginitis
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Metrorrhagia
Vaginal Diseases
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Estrogens
Estrogens, Conjugated (USP)
Hormones