Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menopause
Intervention: Premarin®/MPA formulation A (Drug); Premarin®/MPA formulation B (Drug); Premarin®/MPA formulation C (Drug); Premarin®/MPA currently marketed product (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
The purpose of this trial is to determine the equivalence of 3 new formulations of a
Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed
dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women.
Each subject will participate in the study for approximately 14 weeks, including a screening
evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with
at least a 21-day washout interval between each dose administration.
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
Study design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
Secondary outcome: No secondary outcome
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion
1. Healthy postmenopausal women aged 35 to 70.
2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
3. Nonsmoker or smoker of fewer than 10 cigarettes/day.
Exclusion
1. History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can
take up to 2 antihypertensive medications to keep blood pressure under control.
2. History within 1 year of study day 1 of alcohol or drug abuse.
3. Use of any investigational drug within 30 days before study day 1.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com Additional Information
Starting date: February 2008
Ending date: June 2008
Last updated: March 6, 2008
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