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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopause

Intervention: Premarin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Clinical Details

Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women

Study design: Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Eligibility

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Healthy postmenopausal women aged 35 to 70 years 2. Nonsmoker or smoker of less than 10 cigarettes per day Exclusion Criteria: 1. History or presence of clotting disorders 2. History or presence of cancer 3. Presence of HIV, hepatitis B or hepatitis C 4. History of drug or alcohol abuse

Locations and Contacts

Additional Information

Starting date: June 2005
Last updated: September 26, 2006

Page last updated: August 23, 2015

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