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.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Ovarian Insufficiency; Vaginitis; Metrorrhagia; Menopause
Intervention: Premarin reference tablet (fasted) (Drug); Premarin new tablet (fasted) (Drug); Premarin reference tablet (fed) (Drug); Premarin new tablet (fed) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:CmaxPlasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall Plasma unconjugated equilin pharmacokinetic parameter:Cmax Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Secondary outcome: Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:TmaxPlasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life Plasma unconjugated equilin pharmacokinetic parameter:Tmax Plasma unconjugated equilin pharmacokinetic parameter:AUClast Plasma unconjugated equilin pharmacokinetic parameter:AUCinf Plasma unconjugated equilin pharmacokinetic parameter:MRT Plasma unconjugated equilin pharmacokinetic parameter:half-life Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Female.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Shinjyuku-ku, Tokyo, Japan; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2011
Last updated: December 6, 2011
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