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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01436513
First received: September 16, 2011
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:Cmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:AUCall [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:Tmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:AUClast [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:AUCinf [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:MRT [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated equilin pharmacokinetic parameter:half-life [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
  • Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436513

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01436513     History of Changes
Other Study ID Numbers: B2811002, 3117X3-1112
Study First Received: September 16, 2011
Last Updated: March 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Metrorrhagia
Vaginitis
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
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
Vaginal Diseases
Estrogens, Conjugated (USP)
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 01, 2014